BacT/ALERT - FA Reagent Bottle recallZ-2244-2011 · bioMerieux, Inc. · initiated Apr 13, 2011
Terminated All recalls posted in May 2011
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
The charcoal suspension in a portion of the lot does not meet the intended density.
FDA root cause category: Other
What the company is doing
BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An Acknowledgement and Product Replacement Form was included to be completed and returned to bioMerieux or credit or replacement of unused bottles.
Recall details
- Recall number
- Z-2244-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 13, 2011
- Posted by the FDA
- May 24, 2011
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 327,700 bottles
- Product code
- MDB
- FDA submissions
- K020813
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium
Product description
BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA 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 (bacterial and fungi) from blood and other normally sterile body fluids.
Code information (models, lots, serial numbers)
Catalog number: 259791, Lot umber 1027481, Expiry: December 8, 2011
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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