Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive

FDA device recall Z-1092-2017 · posted 2017-01-24 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NQD

Quantity affected

3204

Distribution

Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.

Date initiated

2016-02-26

Date posted

2017-01-24

Date terminated

2017-06-05

Location

Indianapolis, IN

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