Atlas FDA

Instrumentation Laboratory

42 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 0 recall (Z-2899-2026)Instrumentation Laboratory2026-08-06
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 0005543 recall (Z-2900-2026)Instrumentation Laboratory2026-08-06
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019 recall (Z-2821-2026)Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Cata recall (Z-2822-2026)Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019 recall (Z-2823-2026)Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019 recall (Z-2824-2026)Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019 recall (Z-2825-2026)Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019 recall (Z-2826-2026)Instrumentation Laboratory2026-07-29
GEM Premier 5000 PAK, Part No. 00055360004. recall (Z-1524-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055360008. recall (Z-1525-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055360010. recall (Z-1526-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055360011. recall (Z-1527-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055407504. recall (Z-1528-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055407508. recall (Z-1529-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055407510. recall (Z-1530-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055407511. recall (Z-1531-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000 PAK; Part No. 00055415004. recall (Z-1532-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055415005. recall (Z-1533-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055415008. recall (Z-1534-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055415010. recall (Z-1535-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No: 00055415011. recall (Z-1536-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055430004. recall (Z-1537-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055430008. recall (Z-1538-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Model No. 00055430010. recall (Z-1539-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055430011. recall (Z-1540-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055445004. recall (Z-1541-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055445008. recall (Z-1542-2026)Instrumentation Laboratory2026-03-10
GEM Premier 5000; Part No. 00055445010 & 00055445011. recall (Z-1543-2026)Instrumentation Laboratory2026-03-10
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitu recall (Z-1095-2026)Instrumentation Laboratory2026-01-15
HemosIL SynthAFax. Partial Thromboplastin Time Tests. recall (Z-0938-2026)Instrumentation Laboratory2025-12-17
HemosIL LMW Heparin Controls; Part Number: 0020300200; recall (Z-2323-2025)Instrumentation Laboratory2025-08-13
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic recall (Z-1020-2025)Instrumentation Laboratory2025-01-24
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, f recall (Z-1304-2023)Instrumentation Laboratory2024-09-30
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory recall (Z-1305-2023)Instrumentation Laboratory2024-09-30
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis la recall (Z-1306-2023)Instrumentation Laboratory2024-09-30
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostas recall (Z-1307-2023)Instrumentation Laboratory2024-09-30
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345 recall (Z-0357-2024)Instrumentation Laboratory2023-11-21
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 000243 recall (Z-0358-2024)Instrumentation Laboratory2023-11-21
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Number recall (Z-0359-2024)Instrumentation Laboratory2023-11-21
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemost recall (Z-2578-2023)Instrumentation Laboratory2023-09-12
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 0000028 recall (Z-1014-2022)Instrumentation Laboratory2022-04-28
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplasti recall (Z-0276-2022)Instrumentation Laboratory2021-11-23

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Every clearance here is in the API, with alerts when new ones post.