Z-0352-2024Class II

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322...

Name: Z-0352-2024 Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322...
Creator: Roche Diagnostics Operations, Inc.
Published: 2023-10-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2023-10-03 / Open, Classified

FDA source

Roche Diagnostics Operations, Inc. began a recall of Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus)... on 2023-10-03. FDA classified it as Class II and gives the reason as "Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0352-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-03
Posted: 2023-11-20
Recalling firm: Roche Diagnostics GmbH
Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Product code: GHH Fibrin Split Products
Reason for recall: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/3/23 was sent to customers. Actions Required " Roche recommends using citrated plasma for D-Dimer quantification until further notice. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification, you are required to confirm all results between 0.5 g FEU/mL and 0.675 g FEU/mL with another D-Dimer method or with a citrated plasma sample. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement. " Please complete all sections of the Recall Response Form (TP-01981) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to [email protected]. " File this Urgent Medical Device Correction (UMDC) for future reference. Credit for Confirmatory Testing If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement. Distributor Actions Required " Read the enclosed Customer UMDC TP-01986. " Within 14 days from receipt of this UMDC, distribute a copy of the enclosed Customer UMDC TP-01986 to all customers to whom you have shipped the Tina-quant D-Dimer assays listed above in the last 2 years. " Please complete all sections of the Distributor Recall Response Form (TP-01985) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to [email protected]. " File this UMDC and the enclosed Customer UMDC for future reference. Questions 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 the information contained in this UMDC.
Quantity in commerce: 5,263 kits
Distribution: US Nationwide distribution.
Product codes and lots: All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0352-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0352-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

Product code GHH

K062203Class IITina-Quant D-Dimer Test SystemRoche Diagnostics Corp. / cleared 2007-03-14

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)