Reported Dec 24, 2025 · Ongoing

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443

Is this the product you have?

  • HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Lot codes and dates
  • Part No. 0020007400
  • UDI
    • 08426950087649
    • Lot No. (Exp. Date) N0542231(2026-06-30)
    • N0250088(2027-04-30
    • N0452249 (2027-06-30)
Amount recalled
4,506 units

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.