The Recall Desk

FDA (Devices) recall action 73027

bioMerieux, Inc. recalled 2 products on 2016-02-10

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-02-10
Critical
0
Units
5,482

Why these products were recalled

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-02-10

    bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.

    Product
    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-02-10

    bioMérieux Recalls BacT/ALERT FA Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT FA culture bottles because non-normal shipping conditions may have degraded the media, potentially affecting microbial detection performance.

    Product
    BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Distribution
    0 states