cobas e 801 immunoassay analyzer

FDA Device Recall #Z-1249-2019 — Class II — March 15, 2019

Recall Summary

Recall Number Z-1249-2019
Classification Class II — Moderate risk
Date Initiated March 15, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Roche Diagnostics Corporation
Location Indianapolis, IN
Product Type Devices
Quantity 149

Product Description

cobas e 801 immunoassay analyzer

Reason for Recall

The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.

Distribution Pattern

Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI

Lot / Code Information

All units may experience this issue.

Other Recalls from Roche Diagnostics Corporation

Recall # Classification Product Date
Z-1979-2019 Class II The Tina-quant lgA Gen.2 is an immunoturbidimet... Jun 3, 2019
Z-1928-2019 Class III cobas p 701 post-analytical units, Part Number ... Apr 4, 2019
Z-1927-2019 Class III cobas p 501 post-analytical units, Part Number ... Apr 4, 2019
Z-1194-2019 Class II Albumin BCP Product Usage: ALBP is an in v... Mar 18, 2019
Z-1368-2019 Class II Cobas¿ infinity central lab IT solution Mater... Feb 4, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.