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FDA-Device2025-12-24Class IIIPROCESSING DEFECT

Instrumentation Laboratory HemosIL SynthAFax blood tests recalled for excess preservative

Instrumentation Laboratory
OTHERARCACODEFLILINNY

Stop using affected HemosIL SynthAFax test lots

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
Hazard

Recalled lots were manufactured with double the amount of preservative concentration.

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-0938-2026

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