Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0042-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2019

Date Posted: October 16, 2019

Recall Number: Z-0042-2020

Event ID: 83467

Reason for Recall:

Inaccurately Low Sample Results

Status: Terminated

Product Quantity: 27676 units

Code Information:

All Lots

Distribution Pattern:

AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY

Voluntary or Mandated:

Voluntary: Firm initiated