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 BD Viper LT software, version 3.00H

  • 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 BD Viper LT software, version 3.00Hsee related information
Date Initiated by FirmDecember 14, 2015
Date PostedApril 04, 2017
Recall Status1 Terminated 3 on April 19, 2017
Recall NumberZ-1866-2017
Recall Event ID 76895
510(K)NumberK140447 
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductBD Viper LT software, version 3.00H
Code Information Catalog Number   443157 443153 443155 443156 442947 443902  Version Number    3.00H  3.00H
FEI Number 1119779
Recalling Firm/
Manufacturer		 Bd Diagnostic
54 Loveton Circle Mc 912
Sparks MD 21152
Manufacturer Reason
for Recall		BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
FDA Determined
Cause 2		Software design
ActionRecall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.
Quantity in Commerce2
Distribution2 US customers, 0 Ex-US regions, and 0 distributors 0.
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 = OOI
-
-