Instrumentation Laboratory Co.
FDA Regulatory Profile
Summary
- Total Recalls
- 69
- 510(k) Clearances
- 327
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1542-2026 | Class II | GEM Premier 5000; Part No. 00055445008. | January 20, 2026 |
| Z-1524-2026 | Class II | GEM Premier 5000 PAK, Part No. 00055360004. | January 20, 2026 |
| Z-1541-2026 | Class II | GEM Premier 5000; Part No. 00055445004. | January 20, 2026 |
| Z-1539-2026 | Class II | GEM Premier 5000; Model No. 00055430010. | January 20, 2026 |
| Z-1525-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360008. | January 20, 2026 |
| Z-1538-2026 | Class II | GEM Premier 5000; Part No. 00055430008. | January 20, 2026 |
| Z-1535-2026 | Class II | GEM Premier 5000; Part No. 00055415010. | January 20, 2026 |
| Z-1532-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055415004. | January 20, 2026 |
| Z-1526-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360010. | January 20, 2026 |
| Z-1529-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407508. | January 20, 2026 |
| Z-1543-2026 | Class II | GEM Premier 5000; Part No. 00055445010 & 00055445011. | January 20, 2026 |
| Z-1530-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407510. | January 20, 2026 |
| Z-1528-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407504. | January 20, 2026 |
| Z-1531-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407511. | January 20, 2026 |
| Z-1540-2026 | Class II | GEM Premier 5000; Part No. 00055430011. | January 20, 2026 |
| Z-1533-2026 | Class II | GEM Premier 5000; Part No. 00055415005. | January 20, 2026 |
| Z-1527-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360011. | January 20, 2026 |
| Z-1534-2026 | Class II | GEM Premier 5000; Part No. 00055415008. | January 20, 2026 |
| Z-1537-2026 | Class II | GEM Premier 5000; Part No. 00055430004. | January 20, 2026 |
| Z-1536-2026 | Class II | GEM Premier 5000; Part No: 00055415011. | 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 |
| K183555 | GEM Premier ChemSTAT | February 16, 2019 |
| K183546 | 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 |