Reported Mar 13, 2019 · Terminated

Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

Microbiologics Inc.

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: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Lot codes and dates
  • Catalog Number 8199; Lot Number (original expiration date YYYY/MM/DD
  • new expiration date YYYY/MM/DD)
    • 8199-02 (2019/02/28
    • 2018/03/31)
    • 8199-03 (2019/02/28
    • 2018/03/31)
    • 8199-04 (2019/05/31
    • 2018/06/30)
    • 8199-05 (2019/05/31
    • 2018/06/30)
    • 8199-06 (2019/10/31
    • 2018/11/30)
    • 8199-07 (2019/05/31
    • 2018/06/30)
    • 8199-08 (2019/12/31
    • 2019/01/31)
    • 8199-09 (2019/05/31
    • 2018/06/30)
    • 8199-10 (2020/01/31
    • 2019/02/28)
    • 8199-11 (2020/01/31
    • 2019/02/28)
    • 8199-12 (2020/01/31
    • 2019/02/28)
    • 8199-13 (2020/01/31
    • 2019/02/28)
    • 8199-17 (2020/04/30
    • 2019/05/31)
    • 8199-18 (2020/05/31
    • 2019/06/30)
    • 8199-19 (2020/10/31
    • 2019/11/30)
Amount recalled
704 units

Where it was sold

Why it was recalled

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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 Jun 9, 2020 · Data as of Sep 19, 7:41 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.