Recall Z-2445-2019 ยท DDR Myoglobin, Antigen, Antiserum, Control
Roche Diagnostics Operations, Inc.
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
| Date | Jul 2, 2019 |
| Status | Terminated |
| Reason | The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The fo |
| Root cause | Under Investigation by firm |
| Action | Roche issued the Urgent Medical Device Correction (UMDC) on July 2, 2019 via UPS (signature required), to the consignee. The letter address the problem, health risk and action to take: Instructions provided to manually implement an Extra Wash Cycle (EWC) for the applicable system. If customers have another validated system not impacted by this issue, (i.e. cobas Integra 400 plus) in their lab, it can be used as an alternative for the Tina-quant Myoglobin Gen.2 assay rather programming the special wash.As a long-term solution, Roche will implement required extra wash cycles (EWCs) into the resp |
| Quantity | 4,309 (cobas c311-340 units;cobas c501-3,517 units;cobas c502 452 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM Roche Diagnostics Corp., Jul 21, 2006 |