Recall archive / FDA device enforcement
HemosIL SynthAFax. Partial Thromboplastin Time Tests. — FDA record Z-0938-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Reason
- Recalled lots were manufactured with double the amount of preservative concentration.
- Classification
- Class III
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 4,506 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0938-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30). |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Nov 18, 2025
- Center classification date
- Dec 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.