Z-0938-2026 Class III Ongoing
FDA device recall Z-0938-2026 was initiated by Instrumentation Laboratory on November 18, 2025 and is designated Class III. Reason for recall: Recalled lots were manufactured with double the amount of preservative concentration. The recall status is ongoing. Affected quantity: 4,506 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,506 units
Product Description
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason for Recall
Recalled lots were manufactured with double the amount of preservative concentration.
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.
Code Information
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).