Roche Diagnostics Operations, Inc. Recall: Tina-Quant (Latex) HS Test System (C-Reactive P
Roche Diagnostics Operations, Inc. Recall: Tina-Quant (Latex) HS Test System (C-Reactive P is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Operations, Inc.; Product: Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Late
| Recalling firm | Roche Diagnostics Operations, Inc. |
|---|---|
| Product | 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 l |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA. |
| Recall initiated | 20160226 |
| Recall number | Z-1092-2017 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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