Manufacturer
46 recalls in our database name Instrumentation Laboratory as the manufacturing or recalling firm.
Of the 46 recalls from Instrumentation Laboratory we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling 7,720 units of a coagulation reagent used for evaluating the intrinsic pathway and monitoring heparin therapy over potential microbial contamination.
Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.
Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.
Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.
Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.
Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.
Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.
The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
INSTRUMENTATION LABORATORY COMPANY
Source: Wikidata (Q138457451), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.