Reported May 18, 2022 · Ongoing

HemosIL ReadiPlasTin, Part No. 0020301400

Instrumentation Laboratory

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 ReadiPlasTin, Part No. 0020301400
Lot codes and dates
  • UDI 08426950632887 All in-date lots are affected by this recall.
Amount recalled
1,563 (US); 29,046 (OUS)

Where it was sold

Why it was recalled

Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

This product could cause temporary or reversible health problems — stop using it.

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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, 5:35 PM UTC

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