Class II — Instrumentation Laboratory Co.
| 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 | Terminated |
| Reason | There is a potential for increased imprecision, out of range quality controls and prolonged sample results. |
| Product | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL® ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP® Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. |
| Quantity | 9751 kits |
| Distribution | US Nationwide |
| Initiated | 2018-08-01 |
| Classified | 2018-10-05 |
| Terminated | 2019-04-16 |
| Recall number | Z-0077-2019 |
| 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 Co. (Z-0077-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80932/
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