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U.S. Department of Health and Human Services

Class 2 Device Recall Online TDM Vancomycin Gen. 3 (200 tests)

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 Class 2 Device Recall Online TDM Vancomycin Gen. 3 (200 tests)see related information
Date Initiated by FirmJuly 23, 2019
Create DateOctober 04, 2019
Recall Status1 Terminated 3 on June 08, 2020
Recall NumberZ-0043-2020
Recall Event ID 83467
510(K)NumberK152245 
Product Classification Radioimmunoassay, vancomycin - Product Code LEH
ProductOnline TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Code Information All Lots
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		Inaccurately Low Sample Results
FDA Determined
Cause 2		Under Investigation by firm
Action1. 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 Commerce33979 units
DistributionAK 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LEH
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