Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BIOMERIEUX VIDAS 3

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BIOMERIEUX VIDAS 3 see related information
Date Initiated by Firm October 22, 2019
Create Date March 02, 2020
Recall Status1 Completed
Recall Number Z-0928-2020
Recall Event ID 84464
510(K)Number K141133  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Code Information software versions 1.2 and higher
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact bioMerieux 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
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 in Commerce 738 units
Distribution US
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BIOMERIEUX
-
-