Recall Z-1092-2017 · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Roche Diagnostics Operations, Inc.

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

Date	Jan 24, 2017 (initiated Feb 26, 2016)
Status	Terminated
Reason	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.
Root 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 futur
Quantity	3204
Distribution	Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K042485

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
Roche Diagnostics Corp., Oct 29, 2004