Z-1092-2017 Class II Terminated
FDA device recall Z-1092-2017 was initiated by Roche Diagnostics Operations, Inc. on Feb 26, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jun 5, 2017). Affected quantity: 3204.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 1, 2017
- Initiation Date
- Feb 26, 2016
- Termination Date
- Jun 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3204
Product Description
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
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 Pattern
Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
Code Information
Catalog number: 11972855216, lot number 60445001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1092-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026