Recall Z-0042-2020— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0042-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-23

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-07-23, terminated 2020-06-08. It names one FDA 510(k) clearance: K152245. Product: Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502. Reason: Inaccurately Low Sample Results.

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Terminated: 2020-06-08
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K152245 — ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo)·cleared 2016-01-08

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

Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

Reason for recall

Inaccurately Low Sample Results

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