BacT/ALERT Classic System Software, Blood Culturing System recallZ-0773-2007 · bioMerieux, Inc. · initiated Aug 14, 2006
Terminated All recalls posted in May 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
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
FDA root cause category: Other
What the company is doing
Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.
Recall details
- Recall number
- Z-0773-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 14, 2006
- Posted by the FDA
- May 3, 2007
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 10790 units, total for all models
- Product code
- MDB
- FDA submissions
- K903505
- Distribution
- Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Product description
BacT/ALERT Classic System Software, Blood Culturing System
Code information (models, lots, serial numbers)
All Models
Other devices under the same FDA submission
5 devices cleared under K903505 — 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
Other products in the same recall event
The FDA groups related products into one recall event (event 36826).
- Z-0776-2007 · TerminatedBacT/ALERT 3D 60 Systems Software, Blood Culturing System
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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