—#136624

Product

HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

FDA product code: LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K963213
Affected lot / code info: Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US (nationwide) including PR.

Timeline

Recall initiated: 2015-05-07
Posted by FDA: 2015-06-27
Terminated: 2017-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.