Date Initiated by Firm |
October 27, 2017 |
Create Date |
March 26, 2018 |
Recall Status1 |
Terminated 3 on April 27, 2020 |
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
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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) Database |
510(K)s with Product Code = NQX and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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