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U.S. Department of Health and Human Services

Class 2 Device Recall Creatinine Plus

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  Class 2 Device Recall Creatinine Plus see related information
Date Initiated by Firm May 07, 2015
Date Posted June 27, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-1922-2015
Recall Event ID 71182
510(K)Number K953239  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Creatinine Plus.

Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Code Information Catalog Numbers: 11775685216; 11875566216; 11875582216.
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911 Ext. 249
Manufacturer Reason
for Recall		 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
FDA Determined
Cause 2		 Under Investigation by firm
Action Roche Diagnostics initiated a voluntary recall and the Urgent Medical Device Correction notices were sent via UPS Ground on 05/07/2015 to customers. Customers were notified of the interference and the method sheets and package inserts will be updated with the new interference claims. The firm plans to monitor any non-responding accounts and address those customers with follow-up attempts to distribute recall notices. The firm plans to conduct level B effectiveness checks via fax and phone. Until the new method sheets are available, the Urgent Medical Device Correction serves as the updated labeling. Roche is not requesting return of the affected product. Customers may contact Todd Siesky Corporate Communications Director, Phone: 317.521.3911, Fax: 317.521.4696, E-mail: todd.siesky@roche.com. For technical questions, contact the Customer Support Center at 1-800-428-2336
Quantity in Commerce 6,255 analytical units distributed
Distribution US (nationwide) including PR.
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 = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
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