Roche Diagnostics Operations, Inc. recalls Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive…

Recall date

February 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1092-2017

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome