Z-0103-2021Class III

Tina-quant Complement C4 ver.2, Catalog 05991994190

Name: Z-0103-2021 Tina-quant Complement C4 ver.2, Catalog 05991994190
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-08-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-08-27 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Tina-quant Complement C4 ver.2, Catalog 05991994190 on 2020-08-27. FDA classified it as Class III and gives the reason as "Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the...". 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-0103-2021
Classification: Class III
Status: Terminated
Initiated: 2020-08-27
Posted: 2020-10-13
Terminated: 2024-05-22
Recalling firm: Roche Diagnostics GmbH
Product: Tina-quant Complement C4 ver.2, Catalog 05991994190
Product code: DBI Complement C4, Antigen, Antiserum, Control
Reason for recall: Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. 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: Under Investigation by firm
Action: On August 27, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that this was an expansion of the previous notification sent on September 11, 2019, as new products and lots had been added to the scope of the recall. Customers were asked to do the following: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section of the letter for product replacement information. " Complete all sections of the enclosed fax back form 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. Roche will replace any of the recalled product remaining in your inventory. To receive replacement product, please complete the response form enclosed with the firm's mailing and fax or email it according to the instructions on the form. 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: 180 units
Distribution: Domestic distribution nationwide.
Product codes and lots: lot 36870301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0103-2021	Class III	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-13
Z-0104-2021	Class III	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-13

Product code DBI

K012359Class IITina-Quant Complement C4 Test SystemRoche Diagnostics Corp. / cleared 2001-11-29

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)