FDA Device Recall Z-0042-2020: Roche Diagnostics Operations, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-2020.

Recall Res Number

Z-0042-2020

Recalling Firm / Manufacturer

Roche Diagnostics Operations, Inc.

FEI Number

1823260

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-07-23

Date Posted

N/A

Date Terminated

2020-06-08

Product Code

LEH

Event Number

83467

Product Quantity

27676 units

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

Action Details 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.

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

Code Information / Serial Numbers All Lots

Related Establishments / Registrations

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ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
B.R.A.H.M.S GmbH Registration: 3003561301 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
ARK DIAGNOSTICS INC Registration: 3005755244 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
INPECO SA Registration: 3010825766 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration

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Medical Device Recall: Z-0042-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer