Class III — 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 III |
| Status | Ongoing |
| Reason | Recalled lots were manufactured with double the amount of preservative concentration. |
| Product | HemosIL SynthAFax. Partial Thromboplastin Time Tests. |
| Quantity | 4,506 units |
| Distribution | Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN. |
| Initiated | 2025-11-18 |
| Classified | 2025-12-17 |
| Recall number | Z-0938-2026 |
| 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 III recall — Instrumentation Laboratory (Z-0938-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98019/
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