Roche Diagnostics Operations, Inc.: Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitr

Is my product affected?

Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. High

• UPC 11972855216

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling Tina-Quant Cardiac C-Reactive Protein (Latex) High Sensitive test kits, specifically lot number 604450 (catalog number 11972855216). The tests show an under-recovery of up to -25% at concentrations below 5 mg/L when used on the MODULAR ANALYTICS P module, meaning results can be incorrectly low. C-Reactive Protein is used to assess cardiovascular risk, so an erroneous low result could lead to an inaccurate cardiovascular risk assessment and delay necessary follow-up examinations.

The affected product was distributed nationwide to 13 states: Alabama, Arizona, California, Connecticut, Florida, Georgia, Kansas, Massachusetts, Missouri, New Jersey, New York, Pennsylvania, and Washington. A total of 3,204 units were recalled. The source does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.

Details from the source

Reason for recall: Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination. Distribution: Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA. Quantity: 3204 Lot/code info: Catalog number: 11972855216, lot number 60445001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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