—#183335

Product

Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

FDA product code: JZO — System, Test, Thyroid Autoantibody
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K051890
Affected lot / code info: All current and upcoming lots

Why it was recalled

Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Urgent Medical Device Correction notification letters dated 8/20/20 were distributed to customers. Actions Required " Be aware of the new RF interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheet (V3), anticipated in September 2020, is available. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Customers do not need to perform an additional RF test unless otherwise determined in consultation with the physician or pathologist at your facility. " Complete the attached fax back form (TP-01048) and fax or email it according to the instructions on the form. " File this UMDC for future reference. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. The Elecsys Anti-TPO method sheet is being updated with the new claim for Rheumatoid Factor (RF) interference. Until the updated method sheet (V3) is available, this Urgent Medical Device Correction serves as your labeling. When these method sheets are updated, they will be available on the diagnostics.roche.com website and on the cobas e-library. 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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2020-08-20
Terminated: 2021-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.