[pending] HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Pending LLM rewrite. Source: FDA_DEVICE Z-0938-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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