Cholesterol 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.
Recall
- Recall Number
- Z-1920-2015
- Event Number
- 71182
- Firm
- Roche Diagnostics Operations, Inc.
- FEI Number
- 1823260
- Product Code
- CHH
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 7, 2015
- Posted
- June 27, 2015
- Terminated
- March 24, 2017
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
Cholesterol 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.
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: [email protected]. For technical questions, contact the Customer Support Center at 1-800-428-2336
US (nationwide) including PR.
6,255 analytical units distributed