Class IIIReported 2025-12-24

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Reason for Recall

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

Recall Number

Z-0938-2026

Classification

Class III

Status

Ongoing

Category

device

Initiated

2025-11-18

Reported

2025-12-24

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.

Code Info

Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.