Instrumentation Laboratory: HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Hazard

Recalled lots were manufactured with double the amount of preservative concentration.

Details from the source

Reason for recall: Recalled lots were manufactured with double the amount of preservative concentration. 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. Quantity: 4,506 units Lot/code info: Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).

UPC codes

08426950087649

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.