Tina-Quant Myoglobin Gen.2 (2019-06-27)

Starting date:

June 27, 2019

Posting date:

July 19, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70445

Last updated: 2019-07-19

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  Reason
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  Affected products

Affected Products

Tina-Quant Myoglobin Gen.2

Reason

There is quality controls (QCS) imprecision and calibration failures with the Tina-Quant Myoglobin Gen.2 (Myo2) assay on COBAS c 311/501/502 with reagent lot #34986001. COBAS INTEGRA400 plus/COBAS c 701-702 are not impacted.

Affected products