Recall Z-1824-2011 ยท CIC Cresolphthalein Complexone, Calcium
Roche Diagnostics Operations, Inc.
Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, 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 | Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau |
| 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 | 14,528 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 |