Recall Z-2361-2019 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Roche Diagnostics Operations, Inc.
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
| Date | Aug 23, 2019 (initiated Jul 16, 2019) |
| Status | Terminated |
| Reason | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples. |
| Root cause | Under Investigation by firm |
| Action | Customers will be instructed to only use serum samples when testing with one of the affected lots numbers. Re-measure the sample if an implausible result occurs while using plasma samples, and a high Anti-CCP result does not match the patients clinical picture. To follow the work-around provided in the UMDC concerning pre-analytical sample handling for plasma samples. Perform maintenance according to the operator manual (e.g., Liquid Flow Cleaning [LFC]) to ensure proper functioning of the analyzer or module. Customers will be reminded that sample quality can be affected by fibrin clots an |
| Quantity | 135 units |
| Distribution | AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP Roche Diagnostics, Sep 11, 2008 |