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

Recall number

Z-2445-2019

Recalling firm

Roche Diagnostics Operations, Inc.

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

Status

Terminated

Initiated

2019-07-02

Posted

not on file

Terminated

2021-10-22

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.

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 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. Instruction will be provided to complete the attached fax form. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions. The UMDC will also be available on diagnostics.roche.com. Update: Updated UMDC (TP-00708 version 2) and Fax Back Form (TP-00737) was posted to the diagnostics.roche.com website on 8/2, and mailed to customers on 8/5. The Urgent Medical Device Correction has been updated to include an additional consignee instruction to run the Tina-quant Myoglobin Gen.2 assay in batch mode along with the already implemented Extra Wash Cycles on the cobas c 501 and 502 modules.

Quantity

4,309 (cobas c311-340 units;cobas c501-3,517 units;cobas c502 452 units

Distribution

Nationwide

Lot, serial or model codes

Lot: 349860 and onward

510(k) numbers

["K061683"]

PMA numbers

not on file

Product code

DDR

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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