—#184818

Product

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K191899
Affected lot / code info: Catalog Number 08445605190 08445567190 08253153190 08058580190

Why it was recalled

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

Root cause (FDA determination)

Device Design

Action the firm took

On 11/20/2020, Roche issued Urgent Medical Device Correction notices to customers via phone and fax. Customers were advised to do the following: A Roche Customer Support Center representative will contact the four affected customers by phone and a copy of UMDC TP-01155 will be faxed to the customer. Any customer questions or concerns will be addressed during the phone call.

Recalling firm

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

Distribution

Distribution pattern: Domestic: IL, FL, GA, WV

Timeline

Recall initiated: 2020-11-23
Terminated: 2023-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.