Roche recalls Tina-Quant Myoglobin Gen 2 Tests (lot 349860+) due to calibration failures and QC imprecision from signal drop in reaction kinetics. Affected units may produce inaccurate results.
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.
Roche is recalling Tina-Quant Myoglobin Gen. 2 Tests (lot 349860 and newer) because they can cause calibration failures and inaccurate quality control results. This means test results might be unreliable, potentially affecting patient care.
The tests can cause signal drops in reaction kinetics due to adjacent cell mixing effects. This leads to decreased sample recovery and calibration failures, resulting in inaccurate test results for myoglobin levels.
Healthcare facilities using Roche's cobas c311, c501, or c502 analyzers with the Tina-Quant Myoglobin Gen. 2 Tests (lot 349860 onward) are most at risk. Patients receiving tests using these specific reagents could see inaccurate results.
Check the lot number on the reagent vial (349860 or newer). The product is used with Roche cobas c311, c501, or c502 analyzers for myoglobin testing.
Verify the lot number on the Tina-Quant Myoglobin Gen. 2 Tests reagent vial is 349860 or newer.
If using the reagent, run the myoglobin test in batch mode with a maximum of 39 samples per run to minimize interference.
Roche will update application settings to prevent adjacent cell mixing; this change will be communicated later.
Roche found calibration failures and QC imprecision in the Tina-Quant Myoglobin Gen. 2 Tests due to signal drops in reaction kinetics caused by adjacent cell mixing effects.
The tests may produce inaccurate results, including calibration failures and sporadic quality control imprecision, which could impact patient care.
Check the lot number (349860 or newer). Run tests in batch mode with up to 39 samples per run to reduce interference.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2445-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-2445-2019 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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