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U.S. Department of Health and Human Services

Class 2 Device Recall Enzyme Immunoassay, Vancomycin

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  Class 2 Device Recall Enzyme Immunoassay, Vancomycin see related information
Date Initiated by Firm May 26, 2016
Date Posted August 01, 2016
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-2304-2016
Recall Event ID 74312
510(K)Number K060586  
Product Classification Radioimmunoassay, vancomycin - Product Code LEH
Product ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P)

The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
Code Information 04491050190  ONLINE TDM Vancomycin 100 tests 05108420190  ONLINE TDM Vancomycin 200 tests 04642490190  Hitachi Vancomycin (Modular P) 04642481190  Hitachi Vancomycin (917, MOD P)
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-4343
Manufacturer Reason
for Recall		 Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.
FDA Determined
Cause 2		 Under Investigation by firm
Action Roche sent an Urgent Medical Device Correction letter dated May 26, 2016, to all affected customers via UPS Ground (receipt required) . The letter identified the product the problem and the action needed to be taken by the customer. Customers will be informed to disregard the method comparison data in the package insert and to follow the instructions outlined in UMDC 16-083. Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Affected product under Roche control was placed on hold. Affected product will be reworked to add a sticker referring to customers to UMDC 16-083. Roche is not requesting return of the affected product. Any returned product will be managed according to current procedures. The incorrect method comparison will be removed from the method sheets. Updated method sheets will be released at a later time. Customers may contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.
Quantity in Commerce 53,897 Units distributed
Distribution Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY Foreign:None VA/DOD: See list below
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LEH and Original Applicant = ROCHE DIAGNOSTICS CORP.
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