BacT/ALERT FA Culture Bottles, 30 ml, for in vitro… recallZ-0643-2007 · bioMerieux, Inc. · initiated Jan 11, 2007
Terminated All recalls posted in March 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from bioMerieux, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on/about 01/12/2007.
Recall details
- Recall number
- Z-0643-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 11, 2007
- Posted by the FDA
- Mar 22, 2007
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 2136 cases (100 bottles per case)
- Product code
- MDB
- FDA submissions
- K020813
- Distribution
- Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
Product description
BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
Code information (models, lots, serial numbers)
Lot 1014768
Other devices under the same FDA submission
1 device cleared under K020813 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BACT/ALERT® FABiomerieux , Inc. · System, blood culturing5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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