FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: cobas Liat Analyzer, for in vitro diagnostic use.
- Recall number
- Z-2543-2015
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- cobas Liat Analyzer, for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2015-07-24
- Posted
- 2015-09-02
- Terminated
- 2015-12-23
- Reason
- Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
- Root cause
- Nonconforming Material/Component
- Action
- Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.
- Quantity
- 5 pieces
- Distribution
- US Distribution to the states of :TX and NC.
- Lot, serial or model codes
- Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
- 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