Reported Feb 17, 2021 · Terminated

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the…

Helena Laboratories, Corp.

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: Helena Laboratories, Corp. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131

Is this the product you have?

  • Cascade
  • Abrazo aPTT Test Card - Product Usageare to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only
Lot codes and dates
  • Model Number5722
  • Lot Numbers
    • 1-20-5722 expiration date 90/30/2021
    • 3-20-5722 expiration date 11/30/2021
    • 4-20-5722 expiration date 12/31/2021
Amount recalled
205 total kits

Where it was sold

  • Nationwide

Why it was recalled

Intermittent potential for shorter than expected clot times.

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 Nov 19, 2024 · Data as of Sep 19, 6:56 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.