HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Pending LLM rewrite. Source: FDA_DEVICE Z-0938-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Recalled lots were manufactured with double the amount of preservative concentration.
The recalled product
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Manufacturer
- Instrumentation Laboratory
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Part No. 0020007400
- UDI: 08426950087649
- Lot No. (Exp. Date) N0542231(2026-06-30)
- N0250088(2027-04-30
- N0452249 (2027-06-30).
Distribution
Distributed in 8 states:
- AR
- CA
- CO
- DE
- FL
- IL
- IN
- NY
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