Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Reported: September 4, 2019 Initiated: July 16, 2019 #Z-2362-2019
Product Description
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 550
- Distribution
- AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 550.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2019. Severity: Moderate. Recall number: Z-2362-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11