Roche Elecsys Anti-CCP Immunoassay recall
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Why was Roche Elecsys Anti-CCP Immunoassay 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 550
- Distribution
- AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
- Recall date
- September 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)