Z-0634-2021Class II

Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 -

Name: Z-0634-2021 Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 -
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-11-06
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-11-06 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on... on 2020-11-06. FDA classified it as Class II and gives the reason as "Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0634-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-06
Posted: 2020-12-17
Terminated: 2024-10-18
Recalling firm: Roche Diagnostics GmbH
Product: Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Product code: DCN System, Test, C-Reactive Protein
Reason for recall: Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 6, 2020, the firm mailed customers Urgent Medical Device Correction letters. Customers were informed that the present communication serves as an update to previous UMDCs sent on 9/11/2019, 12/18/2019, and 8/27/2020, in that it includes the new product and lot number listed above. Customer Instructions: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section on page 2 of the UMDC for product replacement information. " Complete all sections of the enclosed faxback form (TP-01128) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall.
Quantity in commerce: 699 units
Distribution: US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.
Product codes and lots: CRPL3 - lot 42402301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0634-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0634-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17

Product code DCN

K083444Class IIC-Reactive Protein (Latex)Roche Diagnostics Corp. / cleared 2009-03-18

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)