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Instrumentation Laboratory FDA Recalls
46 recalls on file across devices, 0 of them Class I and 46 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 Class IIMay 21, 2026The active ingredient concentration in the lysing bag soluti |
| GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 0007743Class IIMay 21, 2026The active ingredient concentration in the lysing bag soluti |
| Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 IntelClass IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzeClass IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzClass IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzeClass IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 0000Class IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzeClass IIMay 8, 2026Potential for Bar Code Reader (BCR) wands, used with the GEM |
| GEM Premier 5000; Part No. 00055415010.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No: 00055415011.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK, Part No. 00055360004.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055407504.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055407511.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055360011.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055407508.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055407510.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055445008.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055360008.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055445004.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055430011.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055360010.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000 PAK; Part No. 00055415004.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055415005.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Model No. 00055430010.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055415008.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055430004.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055445010 & 00055445011.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| GEM Premier 5000; Part No. 00055430008.Class IIJan 20, 2026Confirmed customer complaints indicating that GEM PAKs (cart |
| The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring oClass IIDec 11, 2025Potential for microbial contamination. |
| HemosIL SynthAFax. Partial Thromboplastin Time Tests.Class IIINov 18, 2025Recalled lots were manufactured with double the amount of pr |
| HemosIL LMW Heparin Controls; Part Number: 0020300200;Class IIFeb 3, 2025Multiple complaints indicating lower than expected quality c |
| HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticClass IIDec 18, 2024Control indicating lower than expected quality control (QC) |
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500Class IISep 29, 2023Internal testing identified that the GEM Premier PAKs (cartr |
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00Class IISep 29, 2023Internal testing identified that the GEM Premier PAKs (cartr |
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004Class IISep 29, 2023Internal testing identified that the GEM Premier PAKs (cartr |
| ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulatiClass IIJul 13, 2023Sample misidentification could occur under specific condit |
| ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibriClass IIFeb 3, 2023Removes the test definition for HemosIL Liquid Anti-Xa (PN 0 |
| ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulationClass IIFeb 3, 2023Removes the test definition for HemosIL Liquid Anti-Xa (PN 0 |
| ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/Class IIFeb 3, 2023Removes the test definition for HemosIL Liquid Anti-Xa (PN 0 |
| ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolClass IIFeb 3, 2023Removes the test definition for HemosIL Liquid Anti-Xa (PN 0 |
| HemosIL ReadiPlasTin, Part No. 0020301400Class IIApr 8, 2022Variable and out of specification QC results with HemosIL Re |
| 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 Class IIFeb 22, 2022Updated and revised user instructions issued 7/14/22. Potent |
| HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.Class IIOct 13, 2021The firm has received customer reports of performance issues |
| HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinicalClass IIAug 25, 2021Labeled On-board instrument stability issue for current and |
| HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) aClass IIAug 25, 2021Labeled On-board instrument stability issue for current and |
| HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) aClass IIAug 25, 2021Labeled On-board instrument stability issue for current and |