Device Recall Boehringer Mannheim Cholesterol Assay 의 리콜

Recall

71182

Class 2

Z-1920-2015

2015-05-07

2015-06-27

Terminated

United States

2017-03-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136619

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.

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