Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Recalling company
- Instrumentation Laboratory
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Reason
- Recalled lots were manufactured with double the amount of preservative concentration.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Nov 18, 2025
- Reported
- Dec 24, 2025
- 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.
- Status
- Ongoing
- Quantity
- 4,506 units
- Lot / codes
- Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
- Company location
- Bedford, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0938-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0938-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.