FDA-Device2025-12-24Class IIIPROCESSING DEFECT
Instrumentation Laboratory HemosIL SynthAFax blood tests recalled for excess preservative
What this means
Instrumentation Laboratory recalled specific lots of HemosIL SynthAFax Partial Thromboplastin Time tests because they were manufactured with twice the intended amount of preservative. This could affect test accuracy. No injuries have been reported.
- Check if your medical facility uses HemosIL SynthAFax with lot numbers N0542231, N0250088, or N0452249
- Do not use recalled lots; contact your supplier or Instrumentation Laboratory for replacement
- If tests from recalled lots were already performed, contact your healthcare provider
The agency's original wording
Hazard
Recalled lots were manufactured with double the amount of preservative concentration.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
4,506 units
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2026Want us to check the next one for you?
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