CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report
The Tina-Quant Myoglobin Gen recalled by Roche Diagnostics Operations
Roche Diagnostics Operations is recalling The Tina-Quant Myoglobin Gen, distributed nationwide in the US. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2445-2019
- FDA event ID
- 83351
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2019
- FDA classified
- 30 Aug 2019
- Reported
- 11 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Jul 2019 | Recall initiated by company | |
| 30 Aug 2019 | Classified by FDA | +59 days |
| 11 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is The Tina-Quant Myoglobin Gen recalled?
Yes. Roche Diagnostics Operations recalled The Tina-Quant Myoglobin Gen on 2 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2445-2019.
Why was it recalled?
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.
Which lots are affected?
Lot: 349860 and onward
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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