Reported Sep 11, 2024 · Ongoing

PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

Beckman Coulter Biomedical GmbH

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: Beckman Coulter Biomedical GmbH · Sauerbruchstr. 50 · Munchen · N/A

Is this the product you have?

  • PE Centrifuge Temperature Controlled
  • REFB36366, a component of the Power Express
Lot codes and dates
  • UDI(01)15099590673567/ All serial numbers

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

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, 5:37 PM UTC

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