PlainRecalls

Instrumentation Laboratory

Compiled from official public sources by the editorial team.

38 recalls on record · Latest: Mar 18, 2026

Instrumentation Laboratory Recall Insight

Instrumentation Laboratory appears on 38 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.037% 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 Mar 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 38 entries, severity tagging shows 0 critical, 37 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 38 of 38 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 (38). The date window on this page runs from Oct 27, 2021 to Mar 18, 2026.

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 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 testin…

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. Par…

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…

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: 0…

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.…

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…

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 hepar…

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 prov…

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 hepar…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Instrumentation Laboratory with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.