FDA Medical Device Recalls (openFDA)
Biomerieux Inc: BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Recall number
- Z-0928-2020
- Recalling firm
- Biomerieux Inc
- Product
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Status
- Terminated
- Initiated
- 2019-10-22
- Posted
- not on file
- Terminated
- 2024-08-06
- Reason
- Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
- Root cause
- Software design
- Action
- The firm initiated their field action by an email to their subsidiaries on 10/22/2019. The subsidiaries then notified their customers by 2-day express via Fed Ex. In the US customer letter, customers are instructed to check their software version. If the VIDAS 3 software version is between 1.2.0 and 1.3.1, customers are instructed to check the archiving mode. If the archiving mode is Automatic When Results are Reported then customers are instructed how to configure the workaround, and to contact bioMerieux if the customer has the incorrect software configuration. bioMerieux then instructs impacted customers to review and interpret results in the context of the overall clinical procedure. Once this is completed to complete the acknowledgment form in Attachment A and return it the local bioMerieux representative and confirm receipt of this notice.
- Quantity
- 738 units
- Distribution
- US
- Lot, serial or model codes
- software versions 1.2 and higher
- 510(k) numbers
- ["K141133"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28