⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is Instrumentation Laboratory recalled?

Instrumentation Laboratory recalls - full list & free alerts

Official U.S. agency records list 30 recalls involving Instrumentation Laboratory in the last 12 months, most recently on 2026-08-12. Check each official notice for the exact products, lot codes and dates affected.

Check a lot code, UPC or model number

This is not a guarantee; check the official notice.

Recalls (30)

Instrumentation Laboratory: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Desc
Medical DevicesFDA (device) · 2026-08-12 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 0005544
Medical DevicesFDA (device) · 2026-08-12 · Class II
Instrumentation Laboratory: GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable b
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Manag
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Medical DevicesFDA (device) · 2026-08-05 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK, Part No. 00055360004.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055360008.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055360010.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055360011.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055407504.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055407508.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055407510.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055407511.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000 PAK; Part No. 00055415004.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055415005.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055415008.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055415010.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No: 00055415011.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055430004.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055430008.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Model No. 00055430010.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055430011.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055445004.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055445008.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: GEM Premier 5000; Part No. 00055445010 & 00055445011.
Medical DevicesFDA (device) · 2026-03-18 · Class II
Instrumentation Laboratory: The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Medical DevicesFDA (device) · 2026-01-21 · Class II
Instrumentation Laboratory: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Medical DevicesFDA (device) · 2025-12-24 · Class III
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