Device product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Z-0938-2026
Product summary
- Event
- Event 98019
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4,506 units
- Official record key
device-enforcement:Z-0938-2026
Official wording
Reason: Recalled lots were manufactured with double the amount of preservative concentration.
Code information: Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Distribution pattern: 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.
Derived failure modes
-
Unknown
Recalled lots were manufactured with double the amount of preservative concentration.