Instrumentation Laboratory
Bedford, MA
This page shows every FDA and USDA recall linked to Instrumentation Laboratory. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
18
Total Recalls
2021
First Recall
2026
Most Recent
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the mo...
Jan 15, 2026
· Device
Open, Classified
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Dec 17, 2025
· Device
Open, Classified
HemosIL LMW Heparin Controls;
Part Number: 0020300200;
Aug 13, 2025
· Device
Open, Classified
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Jan 24, 2025
· Device
Open, Classified
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/o...
Sep 30, 2024
· Device
Open, Classified
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for c...
Sep 30, 2024
· Device
Open, Classified
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation an...
Sep 30, 2024
· Device
Open, Classified
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagul...
Sep 30, 2024
· Device
Open, Classified
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007,...
Nov 21, 2023
· Device
Open, Classified
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024...
Nov 21, 2023
· Device
Open, Classified
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Nov 21, 2023
· Device
Open, Classified
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for...
Sep 12, 2023
· Device
Open, Classified
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:
Name Part Number
1.ACL TOP 300 CTS 00000280060
2. ACL TOP 30...
Apr 28, 2022
· Device
Open, Classified
HemosIL ReadiPlasTin, Part No. 0020301400
Apr 8, 2022
· Device
Open, Classified
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Nov 23, 2021
· Device
Open, Classified
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic
use by laboratory professionals i...
Aug 25, 2021
· Device
Open, Classified
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated hepar...
Aug 25, 2021
· Device
Open, Classified
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated hepar...
Aug 25, 2021
· Device
Open, Classified