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Roche Elecsys Anti-CCP Immunoassay recallZ-2362-2019 · Roche Diagnostics Operations, Inc. · initiated Jul 16, 2019

Class II Terminated All recalls posted in August 2019

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

Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

FDA root cause category: Under Investigation by firm

What the company is doing

Customers will be instructed to only use serum samples when testing with one of the affected lots numbers. Re-measure the sample if an implausible result occurs while using plasma samples, and a high Anti-CCP result does not match the patients clinical picture. To follow the work-around provided in the UMDC concerning pre-analytical sample handling for plasma samples. Perform maintenance according to the operator manual (e.g., Liquid Flow Cleaning [LFC]) to ensure proper functioning of the analyzer or module. Customers will be reminded that sample quality can be affected by fibrin clots and how this significantly impacts the Anti-CCP results. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. ***Updated 7/17/20*** An updated letter was sent out to customers on July 13, 2020. After further investigation, Roche has decided to remove human plasma as a sample type from the intended use and remove all claims associated with the plasma sample type. The change is applicable for all current and upcoming lots. Customer actions required: " Use the Elecsys Anti-CCP assay with serum samples only for all current and future Elecsys Anti-CCP lot numbers. " ALL customers, complete the response form included with the letter and return to the firm " If you cannot run serum samples in your laboratory, complete the Product Information section of the response form to obtain reagent credit or contact your Roche sales representative for further options. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. " Discard Urgent Medical Device Correction TP-00714 if you previously received it.

Recall details

Recall number
Z-2362-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 16, 2019
Posted by the FDA
Aug 23, 2019
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
550
Product code
NHX
FDA submissions
K081338
Distribution
AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA

Product description

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

Code information (models, lots, serial numbers)

Lot # 376808 Exp 08/31/2019 Lot # 389165 Exp 09/30/2019  Anti-CCP assay: Anti-CCP Elecsys cobas e 100  The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019.  ***Updated 7/17/20*** Current (in-date) and future lots of both Catalog numbers are impacted.  In-date lots: 443981, exp. 07/31/2020 457164, exp. 09/30/2020

Other devices under the same FDA submission

1 device cleared under K081338 — 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 83416).

Sources and updates

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