Recall Z-0752-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0752-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-23

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-11-23, terminated 2023-07-06. It names one FDA 510(k) clearance: K191899. Product: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use. Reason: 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)..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Terminated: 2023-07-06
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics·cleared 2019-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.