PlainRecalls

Instrumentation Laboratory Co.

24 recalls on record · Latest: Sep 18, 2019

Instrumentation Laboratory Co. Recall Insight

Instrumentation Laboratory Co. appears on 24 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.029% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 18, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 24 entries, severity tagging shows 0 critical, 24 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 24 of 24 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (24). The date window on this page runs from Sep 26, 2012 to Sep 18, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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, …

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 Chr…

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 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…

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 he…

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 he…

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 th…

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 mo…

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…

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 …

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 i…

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 …

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…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds