Z-1092-2017Class II

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

Name: Z-1092-2017 Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High...
Creator: Roche Diagnostics Operations, Inc.
Published: 2016-02-26
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-02-26 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the... on 2016-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1092-2017
Classification: Class II
Status: Terminated
Initiated: 2016-02-26
Posted: 2017-01-24
Terminated: 2017-06-05
Recalling firm: Roche Diagnostics GmbH
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
Product code: NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
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 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 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.
Product codes and lots: Catalog number: 11972855216, lot number 60445001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1092-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1092-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24

Product code NQD

K042485Class IITina-Quant Crp (Latex) Hs Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. / cleared 2004-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)