Recalls / —

—#175319

Product

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

FDA product code

LEH — Radioimmunoassay, Vancomycin

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K152245

Affected lot / code info

All Lots

Why it was recalled

Inaccurately Low Sample Results

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Operations, Inc.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated

2019-07-23

Terminated

2020-06-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.