HemosIL SynthAFax. Partial Thromboplastin Time Tests. recall (Instrumentation Laboratory)
Medical deviceClass IIIOngoing
Summary: Instrumentation Laboratory is recalling HemosIL SynthAFax. Partial Thromboplastin Time Tests.. Reason: Recalled lots were manufactured with double the amount of preservative concentration.
What is being recalled
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Why
Recalled lots were manufactured with double the amount of preservative concentration.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
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. (states named: Arkansas, California, Colorado, Florida, Illinois, Indiana, New York)
How to tell if yours is affected
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0938-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | November 18, 2025 |
| Reported | December 24, 2025 |
| Company | Instrumentation Laboratory |
| Company location | Bedford, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,506 units |
More recalls from Instrumentation Laboratory · all medical device recalls · recalls from November 2025