HemosIL SynthAFax recall
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Why was HemosIL SynthAFax recalled?
Recalled lots were manufactured with double the amount of preservative concentration.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 4,506 units
- 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.
- Recall date
- December 24, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)