FDAFDA · Food and drugs·Recall number Z-0938-2026
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Published December 24, 2025 · Recall initiated: November 18, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Recalled lots were manufactured with double the amount of preservative concentration.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Instrumentation Laboratory
- Distributor
- 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.
- Lot
- Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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