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 | Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results. |
| Product | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 |
| Quantity | 14,894 kits |
| Distribution | Worldwide Distribution - US Nationwide |
| Initiated | 2017-08-02 |
| Classified | 2018-03-03 |
| Terminated | 2019-03-29 |
| Recall number | Z-0895-2018 |
| 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-0895-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79165/
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