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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMERIEUX VIDAS 3

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 Class 2 Device Recall BIOMERIEUX VIDAS 3see related information
Date Initiated by FirmOctober 22, 2019
Create DateMarch 02, 2020
Recall Status1 Terminated 3 on August 06, 2024
Recall NumberZ-0928-2020
Recall Event ID 84464
510(K)NumberK141133 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductBIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Code Information software versions 1.2 and higher
FEI Number 1950204
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactbioMerieux Customer Support Operations
800-682-2666
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionThe 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 in Commerce738 units
DistributionUS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JJE
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