Bac T/ALERT 3D Combination Module recallZ-0613-05 · Biomerieux, Inc. · initiated May 27, 2005
Terminated All recalls posted in September 2005
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
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on May 27, 2005.
Recall details
- Recall number
- Z-0613-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 27, 2005
- Posted by the FDA
- Sep 7, 2005
- Recalling firm
- Biomerieux, Inc.
- Quantity
- 2,001 units
- Product code
- MDB
- FDA submissions
- K903505
- Distribution
- Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK
Product description
Bac T/ALERT 3D Combination Module
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 32377).
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.
How recalls are matched to devices · Editorial policy · Report an error on this page