Date Initiated by Firm | May 09, 2016 |
Create Date | July 15, 2016 |
Recall Status1 |
Terminated 3 on March 24, 2021 |
Recall Number | Z-2216-2016 |
Recall Event ID |
74094 |
510(K)Number | K111387 |
Product Classification |
Respiratory virus panel nucleic acid assay system - Product Code OCC
|
Product | cobas Liat Analyzer |
Code Information |
US-IVD: M1-E-00383 & M1-E-00434 |
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 | Device was released with default pcal/gain settings for
photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions. |
Quantity in Commerce | 2 |
Distribution | Distributed in NC and WA. |
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.
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510(K) Database | 510(K)s with Product Code = OCC
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