Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Recall Z-0043-2020 · Posted None
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeLEH
Date Initiated2019-07-23
Date Terminated2020-06-08
Product Quantity33979 units
Reason for Recall
Inaccurately Low Sample Results
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.
Root Cause
Under Investigation by firm
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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