FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
- Recall number
- Z-2203-2016
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
- Status
- Terminated
- Initiated
- 2016-05-17
- Posted
- 2016-07-13
- Terminated
- 2017-02-01
- Reason
- Kit labeled with the incorrect expiration date.
- Root cause
- Incorrect or no expiration date
- Action
- An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.
- Quantity
- 194 distributed kits
- Distribution
- Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
- Lot, serial or model codes
- Lot Numbers: 51222E, 60121H, 60201D, and 60229F
- 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