Oxoid Agglutinating Sera Salmonella 9-0 Serotyping Classification Error
Remel Europe Ltd. is recalling specific lots of Oxoid Agglutinating Sera, Salmonella 9-0 due to cross-reactivity that may misidentify Salmonella 9-O serotypes as 2-O serotypes in laboratory testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a high-risk pathogen (Salmonella) where a serotyping reagent fails to correctly identify bacterial serotypes. Misidentification of Salmonella serotypes could lead to incorrect clinical diagnosis and treatment decisions, creating risk of harm. No illnesses or injuries have been reported in the source text.
Plain-English summary
Remel Europe Ltd. is recalling multiple lots of Oxoid Agglutinating Sera, Salmonella 9-0 (UDI-DI 05056080500270), a medical device used for Salmonella serotyping in clinical and research laboratories. Affected lots do not meet instructions for use (IFU) criteria and show cross-reactivity with the 2-O antigen within 60 seconds. This cross-reactivity may cause Salmonella 9-O serotypes to be misidentified as 2-O serotypes, potentially leading to incorrect bacterial classification and reporting.
The recalled lots were distributed worldwide and in the United States to laboratories in AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, and WA. Affected lot numbers include 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, and 6233858.
Laboratories using affected lots should discontinue use and contact Remel Europe Ltd. for replacement product or further guidance.
The recalled product
- Product
- Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
- Manufacturer
- Remel Europe Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- UDI-DI 05056080500270 lots 6172600
- 6172741
- 6171393
- 6150168
- 6107767
- 3766399
- 3766400
- 3780497
- 3719592
- 3709358
- 6266130
- 6253410
- 6260215
- 6222350
- 6233859
- 6233858
Distribution
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