Date Initiated by Firm | September 27, 2016 |
Date Posted | November 10, 2016 |
Recall Status1 |
Terminated 3 on July 21, 2017 |
Recall Number | Z-0387-2017 |
Recall Event ID |
75357 |
510(K)Number | K071211 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | Roche COBAS INTEGRA c111
Analyzer, Chemistry (Photometric, Discrete), for clinical use
Product Usage:
The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride. |
Code Information |
04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact | Roche Support Network Customer Support C 800-428-2336 |
Manufacturer Reason for Recall | cobas c 111 analyzers (catalog numbers 04777433001 and
04528778001) with software versions up to and including 4.20 may encounter the following alarm:
7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing
error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run
restarts. If a used cuvette is used again result of the test(s) will be erroneous.
These erroneous results may not be flagged.
Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic
decisions. The medical risk depends on the parameter. |
FDA Determined Cause 2 | Software design |
Action | Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336. |
Quantity in Commerce | 139 |
Distribution | US Nationwide Distribution |
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 = JJE
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