Class II — Instrumentation Laboratory
| Recalling firm | Instrumentation Laboratory Co. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G. |
| Product | HemosIL ReadiPlasTin, Part No. 0020301400 |
| Quantity | 1,563 (US); 29,046 (OUS) |
| Distribution | US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV. |
| Initiated | 2022-04-08 |
| Classified | 2022-05-10 |
| Recall number | Z-1052-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Instrumentation Laboratory (Z-1052-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90012/
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