Reported Aug 21, 2024 · Ongoing

Cepheid, Sample Collection Device, Part: 900-0370

Cepheid

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: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189

Is this the product you have?

  • Cepheid, Sample Collection Device
  • Part900-0370
Lot codes and dates

4 of 4 products · 8 lot codes

Recalled lot codes, grouped by product number
LotExpiration
230397900
  • July 3
  • 2024
230535300
  • July 14
  • 2024
230627500
  • August 4
  • 2024
231877400
  • April 10
  • 2025
Amount recalled
651,150

Where it was sold

Why it was recalled

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test 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

Data as of Sep 19, 7:36 PM UTC

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