Instrumentation Laboratory
FDA Regulatory Profile
Instrumentation Laboratory appears in FDA public data with 77 recalls, 327 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2900-2026, Class II) was initiated on May 21, 2026. Its most recent 510(k) clearance was granted on December 29, 2023.
Summary
- Total Recalls
- 77
- 510(k) Clearances
- 327
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2900-2026 | Class II | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 000554 | May 21, 2026 |
| Z-2899-2026 | Class II | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 | May 21, 2026 |
| Z-2823-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 p | May 8, 2026 |
| Z-2825-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po | May 8, 2026 |
| Z-2821-2026 | Class II | GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/ | May 8, 2026 |
| Z-2824-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 po | May 8, 2026 |
| Z-2822-2026 | Class II | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number | May 8, 2026 |
| Z-2826-2026 | Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po | May 8, 2026 |
| Z-1536-2026 | Class II | GEM Premier 5000; Part No: 00055415011. | January 20, 2026 |
| Z-1530-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407510. | January 20, 2026 |
| Z-1542-2026 | Class II | GEM Premier 5000; Part No. 00055445008. | January 20, 2026 |
| Z-1528-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407504. | January 20, 2026 |
| Z-1524-2026 | Class II | GEM Premier 5000 PAK, Part No. 00055360004. | January 20, 2026 |
| Z-1526-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360010. | January 20, 2026 |
| Z-1535-2026 | Class II | GEM Premier 5000; Part No. 00055415010. | January 20, 2026 |
| Z-1533-2026 | Class II | GEM Premier 5000; Part No. 00055415005. | January 20, 2026 |
| Z-1531-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407511. | January 20, 2026 |
| Z-1529-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407508. | January 20, 2026 |
| Z-1541-2026 | Class II | GEM Premier 5000; Part No. 00055445004. | January 20, 2026 |
| Z-1540-2026 | Class II | GEM Premier 5000; Part No. 00055430011. | January 20, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233790 | ACL TOP 970 CL | December 29, 2023 |
| K230852 | HemosIL Chromogenic Factor IX | December 13, 2023 |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | September 29, 2023 |
| K223608 | GEM Premier 7000 with IQM3 | August 10, 2023 |
| K223187 | HemosIL Liquid Anti-Xa | June 23, 2023 |
| K231031 | ACL TOP Family 70 Series | June 21, 2023 |
| K223090 | GEM Premier ChemSTAT | January 27, 2023 |
| K223402 | HemosIL von Willebrand Factor Antigen | December 9, 2022 |
| K213464 | HemosIL Liquid Anti-Xa | October 4, 2022 |
| K213426 | HemosIL ReadiPlasTin | August 16, 2022 |
| K203790 | GEM Premier 5000 | August 20, 2021 |
| DEN190032 | HemosIL Liquid Anti-Xa | September 17, 2020 |
| K200033 | HemosIL von Willebrand Factor Antigen | August 19, 2020 |
| K183546 | GEM Premier ChemSTAT | February 16, 2019 |
| K183555 | GEM Premier ChemSTAT | February 16, 2019 |
| K183549 | GEM Premier ChemSTAT | February 16, 2019 |
| K180486 | HemosIL Factor XII Deficient Plasma | March 22, 2018 |
| K173403 | GEM Premier 5000 | December 29, 2017 |
| K172903 | HemosIL D-Dimer HS 500 | November 22, 2017 |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | September 8, 2017 |