FDA Medical Device Recalls (openFDA)
Remel Europe Ltd.: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Recall number
- Z-1923-2026
- Recalling firm
- Remel Europe Ltd.
- Product
- Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Status
- Open, Classified
- Initiated
- 2026-03-25
- Posted
- 2026-04-22
- Terminated
- not on file
- Reason
- Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
- Root cause
- Under Investigation by firm
- Action
- Firm began notifying consignees on March 25, 2026 via letters titled "Urgent: Medical Device Recall." Laboratory professionals are advised to review results and destroy any remaining inventory of affected lots. Affected lots should not be used for any clinical laboratory testing. Customers should complete and return the included acknowledgement form for replacement/credit to be processed. Notice should be passed on to all who need to be aware. Firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
- Quantity
- 117 US; 950 OUS
- Distribution
- Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.
- Lot, serial or model codes
- UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GRM
- Firm FEI
- 3003750284
- Firm city
- West Ken Dartford
- Firm state
- not on file
- Firm country
- United Kingdom
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