Class 2 Device Recall TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)

• Date Initiated by Firm: February 26, 2016
• Date Posted: January 24, 2017
• Recall Status: Terminated on June 05, 2017
• Recall Number: Z-1092-2017
• Recall Event ID: 75711
• 510(K)Number: K042485
• Product Classification: Cardiac c-reactive protein, antigen, antiserum, and control - Product Code NQD
• 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 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
• Code Information: Catalog number: 11972855216, lot number 60445001
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-428-2336
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Roche Diagnostics sent a Reagent Bulletin dated February 26, 2016, to all affected consignees. The recall notifications included a description of the reason for the recall, affected product, request for replacement, and consignee responsibilities; the notification did not include instructions for responding to the recall notification. Actions Required " Do not use CRPHS lot number 604450. If you have any affected product in your inventory, discard it per local guidelines. " Complete the attached replacement request form to receive replacement product. " File this Reagent Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this Reagent Bulletin.
• Quantity in Commerce: 3204
• Distribution: Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NQD and Original Applicant = ROCHE DIAGNOSTICS CORP.