FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: cobas Liat Analyzer
- Recall number
- Z-2216-2016
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- cobas Liat Analyzer
- Status
- Terminated
- Initiated
- 2016-05-09
- Posted
- not on file
- Terminated
- 2021-03-24
- Reason
- Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
- Root cause
- Under Investigation by firm
- Action
- Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions.
- Quantity
- 2
- Distribution
- Distributed in NC and WA.
- Lot, serial or model codes
- US-IVD: M1-E-00383 & M1-E-00434
- 510(k) numbers
- ["K111387"]
- PMA numbers
- not on file
- Product code
- OCC
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- 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