Date Initiated by Firm | May 07, 2015 |
Date Posted | June 27, 2015 |
Recall Status1 |
Terminated 3 on March 24, 2017 |
Recall Number | Z-1927-2015 |
Recall Event ID |
71182 |
510(K)Number | K012287 |
Product Classification |
System, test, low density, lipoprotein - Product Code MRR
|
Product | LDL-Cholesterol gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. |
Code Information |
Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
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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 | 6255 |
Distribution | US (nationwide) including PR. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MRR
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