Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part numbe
FDA device recall Z-1823-2011 · posted 2011-03-25 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CIC
- Quantity affected
- 13, 405 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-10-11
- Date posted
- 2011-03-25
- Date terminated
- 2011-09-13
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292) | Roche Diagnostic Systems, Inc. | 1996-10-31 |