Z-0043-2020Class II

Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c...

Name: Z-0043-2020 Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-07-23
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-07-23 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502 on 2019-07-23. FDA classified it as Class II and gives the reason as "Inaccurately Low Sample Results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0043-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Posted: 2019-10-04
Terminated: 2020-06-08
Recalling firm: Roche Diagnostics GmbH
Product: Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Product code: LEH Radioimmunoassay, Vancomycin
Reason for recall: Inaccurately Low Sample Results
FDA root cause: Under Investigation by firm
Action: 1. Consignees will be provided instruction to download the updated e-barcode either from the cobas link or from the cobas e-library when available. 2. If analyzers cobas link is not connected to the Roche network, a future version of the cobas e-library CD will contain the revised e-barcodes. Download the e-barcode when available. 3. If analyzers cobas link is not connected to the Roche network and they require the updated VANC3 application e-barcode before the cobas e-library CD is available, they will be instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336 to request a Field Application Specialist to provide the VANC3 updated application. 4. Calibrate and run quality controls (QC) before running samples. 5.Complete all sections of the enclosed fax form. 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.
Quantity in commerce: 33979 units
Distribution: 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
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0043-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0042-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04
Z-0043-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code LEH

K152245Class IIONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo) / cleared 2016-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)