Lower riskMedical device recall · FDA · Published October 22, 2019
Biomerieux VIDAS 3 Immunoanalyzer Recall: Expired Calibration May Cause False Results
Biomerieux recalls VIDAS 3 compact immunoanalyzer with software versions 1.2+ due to expired calibration causing false test results. Affected units may need recalibration.
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.
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Contact the company
📍Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320
✎ GovInfoNow plain-language explainer
Biomerieux is recalling its VIDAS 3 immunoanalyzer devices with software versions 1.2 and higher because the calibration system may show expired calibrations as valid, leading to false test results. This could affect medical testing accuracy if the device is used without proper calibration checks. Read more at govinfonow.com/recall/66620-biomerieux-vidas-3-immunoanalyzer-recall-expired-calibration-may-cause-false.
“Biomerieux VIDAS 3 Immunoanalyzer Recall: Expired Calibration May Cause False Results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66620-biomerieux-vidas-3-immunoanalyzer-recall-expired-calibration-may-cause-false. Based on FDA recall #Z-0928-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2020%22&limit=1).
The FDA announced on Oct. 22, 2019, that Biomerieux Inc is recalling the VIDAS 3 Compact immunoanalyzer due to a software error causing false results from expired calibrations. The agency issued recall number Z-0928-2020 for the Class II device distributed in the US.
How to tell if you have it
Brand: Biomerieux
Product: BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Software versions: 1.2 and higher
The hazard
The hazard involves potentially false results obtained on the VIDAS 3 due to expired calibration. The software incorrectly updated the calibration status, allowing assays with expired calibrations to compute results without displaying an alarm to warn users.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Recent similar recalls include the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the Biomerieux VITEK 2 Gram-negative Susceptibility Cards recall (Jan. 5, 2026). Other recent recalls of similar products include the Healthmark ProChek-II recall (July 29, 2026) and the Vivoo Protein Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check if your device has the name 'BIOMERIEUX VIDAS 3' and software version 1.2 or higher. The recall covers devices sold with full traceability and automation features.
Brand
Biomerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version to confirm it is 1.2 or higher.
How this recall unfolded
Recall timeline
FDA terminated this recall 4.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0928-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0928-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.