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U.S. Department of Health and Human Services

Class 2 Device Recall Boehringer Mannheim Cholesterol Assay

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 Class 2 Device Recall Boehringer Mannheim Cholesterol Assaysee related information
Date Initiated by FirmMay 07, 2015
Date PostedJune 27, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall NumberZ-1920-2015
Recall Event ID 71182
510(K)NumberK952127 
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
ProductCholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Code Information Catalog Numbers: 11491458216; 11875540216; 11875523216.
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTodd 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
ActionRoche 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 Commerce6,255 analytical units distributed
DistributionUS (nationwide) including PR.
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 = CHH
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