PlainRecalls

Instrumentation Laboratory

Compiled from official public sources by the publisher.

46 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

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

#388 of 14,151 · 46 notices · 0.044% archive

  • BOOK 46 notices
  • RANK #388 of 14,151
  • SHARE 0.044% archive
  • AGENCY FDA Devices (46)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Alphatec Spine, Inc.

Nearest notice-volume peer: Alphatec Spine, Inc. (0 notice gap)

Instrumentation Laboratory accounts for about 0.044% of the 104,423-notice archive on 46 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 →

Instrumentation Laboratory's standing among 14,151 recalling firms

Instrumentation Laboratory ranks 388th 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

46 388th of 14151 higher than 13,761 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 holds about 0.044% of archive notices alongside 46 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 12, 2026

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
FDA Devices Moderate Aug 12, 2026

GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
FDA Devices Moderate Aug 5, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Devices Moderate Aug 5, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Devices Moderate Aug 5, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Devices Moderate Aug 5, 2026

Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
FDA Devices Moderate Aug 5, 2026

GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
FDA Devices Moderate Aug 5, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK, Part No. 00055360004.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055415005.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Model No. 00055430010.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055430008.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055415008.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055407511.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055360011.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055407508.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055445008.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055407510.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055360008.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055445004.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055415010.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055430004.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No: 00055415011.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055430011.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055360010.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055415004.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000; Part No. 00055445010 & 00055445011.
FDA Devices Moderate Mar 18, 2026

GEM Premier 5000 PAK; Part No. 00055407504.
FDA Devices Moderate Jan 21, 2026

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
FDA Devices Low Dec 24, 2025

HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA Devices Moderate Aug 20, 2025

HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Devices Moderate Feb 5, 2025

HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
FDA Devices Moderate Sep 20, 2023

ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number:

FDA Devices Moderate Apr 5, 2023

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Devices Moderate Apr 5, 2023

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Devices Moderate Apr 5, 2023

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Devices Moderate Apr 5, 2023

ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Devices Moderate May 18, 2022

HemosIL ReadiPlasTin, Part No. 0020301400
FDA Devices Moderate May 4, 2022

ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
FDA Devices Moderate Dec 1, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601
FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600

Instrumentation Laboratory holds a measurable archive slice

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (46 here — heavy-book).

Alphatec Spine, Inc. 46 Amerisource Health Services LLC 46 Ford,Mercury 46 Gm Manufacturing Inc. 46 Lexus,Toyota 46

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Alphatec Spine, Inc. 46 Respironics California, LLC 46 Arrow International, LLC 47 Medtronic 47

Frequently Asked Questions

How many federal recall notices name Instrumentation Laboratory? ▼
PlainRecalls indexes 46 distinct federal recall events naming Instrumentation Laboratory, 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 ranks #388 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th 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 46 of this firm's 46 indexed notices.
What product category dominates Instrumentation Laboratory's filing book? ▼
Filings for Instrumentation Laboratory 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: 46 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; individual notices remain authoritative on each linked recall page.

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