Skip to content

Cholesterol Gen.2 recallZ-1921-2015 · Roche Diagnostics Operations, Inc. · initiated May 7, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1921-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 7, 2015
Posted by the FDA
Jun 27, 2015
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
6,255 analytical units distributed
Product code
CHH
FDA submissions
K031824
Distribution
US (nationwide) including PR.

Product description

Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.

Code information (models, lots, serial numbers)

Catalog Numbers: 04718917190; 03039773190; 05168538190; 03039773190.

Other devices under the same FDA submission

4 devices cleared under K031824 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 71182).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page