Reported Mar 14, 2018 · Terminated

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Instrumentation Laboratory Co.

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 Co. · 180 Hartwell Rd · Bedford, MA · 01730-2443

Is this the product you have?

    • Hemosll ReadiPlasTin (20 ml Size)
    • Part Number 0020301400
Lot codes and dates
  • Lots
    • N1166235
    • N0177760
    • N0278358
    • N0478057
    • N0479504 & N0278177
Amount recalled
14,894 kits

Where it was sold

  • Nationwide

Why it was recalled

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

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

Notice updated Mar 29, 2019 · Data as of Sep 19, 4:45 PM UTC

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