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U.S. Department of Health and Human Services

Class 2 Device Recall Enzymatic assay for the determination of Acetaminophen

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  Class 2 Device Recall Enzymatic assay for the determination of Acetaminophen see related information
Date Initiated by Firm January 02, 2018
Create Date April 25, 2018
Recall Status1 Terminated 3 on April 25, 2019
Recall Number Z-1519-2018
Recall Event ID 79526
510(K)Number K110726  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminophen150 test
Code Information Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18036001 11/30/2017 11071600 8/10/2016 19329601 1/31/2018 11101500 1/21/2016 20511301 5/31/2018 11111600 4/30/2018 24076801 8/31/2018 60482201 2/29/2016 60852601 5/31/2016 61385701 9/30/2016 62032101 1/31/2017
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Amanda Biedess
317-5214343
Manufacturer Reason
for Recall		 The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."
FDA Determined
Cause 2		 Error in labeling
Action On January 2, 2018 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers with notification to the issue and information regarding the updated method sheets and that they were available for use. The COBAS INTEGRA 400 plus/800/800 CTS was updated from affected method sheet version 3.0 to 4.0. The MODULAR ANALYTICS P was updated from affected method sheet version 4.0 to 5.0 No product return is required. 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 Commerce 35,111
Distribution Nationwide Distribution
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 = LDP and Original Applicant = Roche Diagnostics
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