Reported Feb 1, 2017 · Terminated
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- 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
- Lot codes and dates
- Catalog number
11972855216lot number 60445001
- Catalog number
- Amount recalled
- 3204
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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