FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: cobas e 801 immunoassay analyzer
- Recall number
- Z-1249-2019
- Recalling firm
- Roche Diagnostics Corporation
- Product
- cobas e 801 immunoassay analyzer
- Status
- Terminated
- Initiated
- 2019-03-15
- Posted
- not on file
- Terminated
- 2020-04-23
- Reason
- 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.
- Root cause
- Device Design
- Action
- On March 15, 2019, the firm notified affected customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the potential problem of signal drops when the standby bottle flowpath is covered with a biofilm. Customers were asked to do the following: " Follow the Workaround section to determine if your cobas e 801 module is potentially affected and perform the steps if applicable. " If your cobas e 801 module is potentially affected based on the information in the Workaround section of this UMDC, contact the Roche Support Network Customer Support Center at 1-800-428-2336 to schedule the ProCell II M flowpath decontamination procedure. The ProCell II M flowpath decontamination procedure should be performed every 4 weeks until your cobas e 801 module is switched to the improved ProCell II M formulation. " Identify and retest potentially affected patient samples using the Retrospectively Identify and Correct Potentially Affected Patient Sample Results section of this UMDC. " Complete the attached fax form and fax it to 1-833-254-2597 or email it to roche10068@stericycle.com.
- Quantity
- 149
- Distribution
- 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, serial or model codes
- All units may experience this issue.
- 510(k) numbers
- ["K100853","K162606","K163569"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28