Recall Z-1823-2011 ยท CIC Cresolphthalein Complexone, Calcium
Roche Diagnostics Operations, Inc.
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.
| Date | Mar 25, 2011 (initiated Oct 11, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 13, 405 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc., Oct 31, 1996 |