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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas

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  Class 2 Device Recall Cobas see related information
Date Initiated by Firm October 27, 2017
Create Date March 26, 2018
Recall Status1 Open3, Classified
Recall Number Z-1195-2018
Recall Event ID 79375
510(K)Number K142721  
Product Classification System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen - Product Code NQX
Product Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Code Information Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact
908-253-7200
Manufacturer Reason
for Recall
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
FDA Determined
Cause 2
Software design
Action The cobas MRSA/SA tests has the potential for decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others.
Quantity in Commerce 136 kits
Distribution Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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