Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of WerfenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Instrumentation Laboratory with 331 510(k) clearances and 79 device recalls. The most recent is a 510(k) clearance dated Mar 20, 2026: HemosIL Factor V Leiden (APC Resistance V).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 20, 2026 | HemosIL Factor V Leiden (APC Resistance V)K260551 · GGW | 510(k) clearances |
| Jan 9, 2026 | HemosIL Silica Clotting TimeK253957 · GFO | 510(k) clearances |
| Jul 24, 2025 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLK251968 · KQJ | 510(k) clearances |
| Jan 28, 2025 | HemosIL CL HIT-IgG(PF4-H)K243374 · LCO | 510(k) clearances |
| Aug 16, 2024 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)K242127 · GKP | 510(k) clearances |
| Dec 29, 2023 | ACL TOP 970 CLK233790 · JPA | 510(k) clearances |
| Dec 13, 2023 | HemosIL Chromogenic Factor IXK230852 · GGP | 510(k) clearances |
| Sep 29, 2023 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK221359 · JPA | 510(k) clearances |
| Jul 23, 2019 | ROTEM ex-tem Canada Part No: 503-05-CAClass II · Prolonged clotting times | Device recalls |
| Jul 23, 2019 | ROTEM ex-tem Rest of the world part No: 503-05 (ROW)Class II · Prolonged clotting times | Device recalls |
| Jul 23, 2019 | ROTEM ex-tem; US Part No: 503-05-USClass II · Prolonged clotting times | Device recalls |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin Class II · There is a potential for increased imprecision, out of range quality controls and prolonged sample results. | Device recalls |
| Aug 2, 2017 | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400Class II · Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and | Device recalls |
| Dec 18, 2015 | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 xClass II · This Lot is not meeting labeled on-board instrument stability claims of 5 days. | Device recalls |
| Nov 21, 2014 | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinClass II · Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit | Device recalls |
| Jun 3, 2014 | ACL TOP 500 CTS, automated coagulation laboratory instrument.Class II · Potential for sample misidentification. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
