| Class 2 Device Recall Calcium test system | |
Date Initiated by Firm | October 11, 2010 |
Date Posted | March 25, 2011 |
Recall Status1 |
Terminated 3 on September 13, 2011 |
Recall Number | Z-1823-2011 |
Recall Event ID |
57455 |
510(K)Number | K963292 |
Product Classification |
Cresolphthalein complexone, calcium - Product Code CIC
|
Product | Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN.
For the in vitro quantitative determination of calcium in serum, plasma and urine. |
Code Information |
Lots 62601901 and 63020401. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Road Indianapolis IN 46256-1025
|
For Additional Information Contact | Betsy Cox 317-576-2000 Ext. 249 |
Manufacturer Reason for Recall | The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401. |
FDA Determined Cause 2 | Other |
Action | The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference.
The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.
Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter. |
Quantity in Commerce | 13, 405 units |
Distribution | Nationwide distribution. |
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 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 = CIC
|
|
|
|