HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reported: December 24, 2025 Initiated: November 18, 2025 #Z-0938-2026
Product Description
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason for Recall
Recalled lots were manufactured with double the amount of preservative concentration.
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 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.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
HemosIL SynthAFax. Partial Thromboplastin Time Tests.. Recalled by Instrumentation Laboratory. Units affected: 4,506 units.
Why was this product recalled? ▼
Recalled lots were manufactured with double the amount of preservative concentration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Low. Recall number: Z-0938-2026.
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