—#183650

Product

Tina-quant Complement C4 ver.2, Catalog 05991994190

FDA product code: DBI — Complement C4, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K012359
Affected lot / code info: lot 36870301

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Domestic distribution nationwide.

Timeline

Recall initiated: 2020-08-27
Terminated: 2024-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.