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Instrumentation Laboratory Co.

31 recalls on record · Latest: Sep 18, 2019

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Agency notice ledger

Federal filing book Instrumentation Laboratory… MID-BOOK · SINGLE-AGENCY

#541 of 14,151 · 31 notices · 0.030% archive

  • BOOK 31 notices
  • RANK #541 of 14,151
  • SHARE 0.030% archive
  • AGENCY FDA Devices (31)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 18, 2019
  • PHOTO Abbott Point Of Care…

Nearest notice-volume peer: Abbott Point Of Care Inc. (0 notice gap)

Instrumentation Laboratory Co. accounts for about 0.030% of the 104,423-notice archive on 31 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Instrumentation Laboratory… compares to 14,151 recalling firms

Instrumentation Laboratory Co. ranks 541st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Instrumentation Laboratory… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

31 541st of 14151 higher than 13,601 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Instrumentation Laboratory… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Instrumentation Laboratory Co. holds about 0.030% of archive notices alongside 31 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem Canada Part No: 503-05-CA

FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem; US Part No: 503-05-US

FDA Devices Moderate Oct 17, 2018

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

FDA Devices Moderate Mar 14, 2018

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

FDA Devices Moderate Feb 10, 2016

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

FDA Devices Moderate Dec 31, 2014

HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

FDA Devices Moderate Jul 23, 2014

ACL TOP 500 CTS, automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP (Base), automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP 700, automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP 700 LAS, automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP 700 CTS, automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP 300 CTS, automated coagulation laboratory instrument.

FDA Devices Moderate Jul 23, 2014

ACL TOP CTS, automated coagulation laboratory instrument.

FDA Devices Moderate Dec 25, 2013

HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

FDA Devices Moderate Dec 25, 2013

HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

FDA Devices Moderate Dec 25, 2013

HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220

FDA Devices Moderate Sep 25, 2013

ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Sep 25, 2013

ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

FDA Devices Moderate Jul 31, 2013

HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

Instrumentation Laboratory… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Instrumentation Laboratory…?
PlainRecalls indexes 31 distinct federal recall events naming Instrumentation Laboratory Co., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Instrumentation Laboratory… sit among other recalling firms?
Instrumentation Laboratory Co. ranks #541 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Instrumentation Laboratory…'s notices?
FDA Devices accounts for 31 of this firm's 31 indexed notices.
What product category dominates Instrumentation Laboratory…'s filing book?
Filings for Instrumentation Laboratory Co. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Instrumentation Laboratory Co.: 31 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Instrumentation Laboratory Co.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026