Instrumentation Laboratory
Instrumentation Laboratory holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2023, with 40 FDA device recalls on record.
Top product codes for Instrumentation Laboratory
FDA recalls by Instrumentation Laboratory
10 most recent of 40- Z-2900-2026 — GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
- Z-2899-2026 — GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
- Z-1535-2026 — GEM Premier 5000; Part No. 00055415010.
- Z-1524-2026 — GEM Premier 5000 PAK, Part No. 00055360004.
- Z-1541-2026 — GEM Premier 5000; Part No. 00055445004.
- Z-1542-2026 — GEM Premier 5000; Part No. 00055445008.
- Z-1531-2026 — GEM Premier 5000 PAK; Part No. 00055407511.
- Z-1540-2026 — GEM Premier 5000; Part No. 00055430011.
- Z-1526-2026 — GEM Premier 5000 PAK; Part No. 00055360010.
- Z-1529-2026 — GEM Premier 5000 PAK; Part No. 00055407508.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Instrumentation Laboratory
Data sourced from openFDA. This site is unofficial and independent of the FDA.