device · product 1 of 1
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
- Recall number
- Z-2445-2019
- Initiated
- July 02, 2019
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 4,309 (cobas c311-340 units;cobas c501-3,517 units;cobas c502 452 units
App-derived interpretation
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 following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
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 following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.
Code information
Lot: 349860 and onward
Distribution pattern
Nationwide