Recall Z-1823-2011
Roche Diagnostics Operations, Inc. · initiated October 11, 2010
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.
Codes / lots: Lots 62601901 and 63020401.
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: Other
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.
Details
- Recall number
- Z-1823-2011
- Initiated
- October 11, 2010
- Posted by FDA
- March 25, 2011
- Terminated
- September 13, 2011
- Product code
- CIC – Cresolphthalein Complexone, Calcium
- Quantity
- 13, 405 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1824-2011 | Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche…Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant… | 10/11/2010Terminated |