Lower risk Medical device recall · FDA · Published July 2, 2019

Roche Tina-Quant Myoglobin Gen 2 Tests Recall: Calibration Failures and QC Imprecision

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2445-2019Medical device Roche ›

Lower-risk 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.

Take action

Contact the company

Recalling firmRoche Diagnostics Operations, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67515-roche-tina-quant-myoglobin-gen-2-tests-recall-calibration-failures.

Source Summary by GovInfoNow · govinfonow.com/recall/67515-roche-tina-quant-myoglobin-gen-2-tests-recall-calibration-failures · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2445-2019

Cite this page

“Roche Tina-Quant Myoglobin Gen 2 Tests Recall: Calibration Failures and QC Imprecision.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67515-roche-tina-quant-myoglobin-gen-2-tests-recall-calibration-failures. Based on FDA recall #Z-2445-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2445-2019%22&limit=1).

The FDA announced on July 2, 2019, that Roche Diagnostics Operations, Inc. is recalling The Tina-Quant Myoglobin Gen. 2 Tests system due to calibration failures and quality control imprecision. The agency issued the recall for the immuno-turbidimetric assay used on specific Roche analyzers.

How to tell if you have it

Brand: Roche
Product: The Tina-Quant Myoglobin Gen. 2 Tests system
Catalog number: 04580010190
Lot numbers: 349860 and onward
Compatible analyzers: cobas c311, cobas c501, and cobas c502

The hazard

Internal investigations confirmed customer complaints of calibration failures and sporadic quality control imprecision caused by a drop in signal in the reaction kinetics. This signal drop, traced to an adjacent cell mixing effect, can decrease sample recovery by up to -30% and affect calibration, QC, and patient samples.

Context

GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 16, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026) and the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025). Other recent recalls of similar products include the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).

How to tell if you have this one

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.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Number
Verify the lot number on the Tina-Quant Myoglobin Gen. 2 Tests reagent vial is 349860 or newer.
Run Tests Separately
If using the reagent, run the myoglobin test in batch mode with a maximum of 39 samples per run to minimize interference.
Update Application Settings
Roche will update application settings to prevent adjacent cell mixing; this change will be communicated later.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Jul 2, 2019Firm started the recall
Aug 30, 2019FDA classified it Class II
Sep 11, 2019Published in FDA’s Enforcement Report
Oct 22, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67515-roche-tina-quant-myoglobin-gen-2-tests-recall-calibration-failures">Roche Tina-Quant Myoglobin Gen 2 Tests Recall: Calibration Failures and QC Imprecision (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2445-2019 (July 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2445-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.