Recall Z-2445-2019— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-07-02, terminated 2021-10-22. It names one FDA 510(k) clearance: K061683. Product: 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. 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 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..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-02
- Terminated
- 2021-10-22
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.