Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
This recall has been terminated (originally issued August 23, 2019).
- Recall Initiated
- July 16, 2019
- Posted
- August 23, 2019
- Terminated
- April 30, 2021
- Recall Number
- Z-2362-2019
- Quantity
- 550
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.