BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic… recallZ-0644-2007 · bioMerieux, Inc. · initiated Dec 19, 2006
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
Bottle data is not sent to BacT/ALERT 3D instrument.
FDA root cause category: Other
What the company is doing
A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
Recall details
- Recall number
- Z-0644-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 19, 2006
- Posted by the FDA
- Mar 22, 2007
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 1233 disks
- Product code
- MDB
- FDA submissions
- K903505, K934593, K954468, K981736
- Distribution
- Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
Product description
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA
Code information (models, lots, serial numbers)
All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
Other devices under the same FDA submission
5 devices cleared under K903505, K934593, K954468, K981736 — 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® 3D CONTROL MODULE 210147Biomerieux , Inc. · System, blood culturing1 death18 reports
- BACT/ALERT® 3D RIGHT COMBINATION MODULE 200290Biomerieux , Inc. · System, blood culturing8 reports
- BACT/ALERT® 3D RIGHT INCUBATION MODULE 210161Biomerieux , Inc. · System, blood culturing4 reports
- BACT/ALERT® 3D LEFT COMBINATION MODULE 200291Biomerieux , Inc. · System, blood culturing3 reports
- BACT/ALERT® 3D LEFT INCUBATION MODULE 210159Biomerieux , Inc. · System, blood culturing3 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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