Remel Shigella sonnei Agglutinating Serum Recalled for Failure to Agglutinate
Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a diagnostic reagent that may lead to inaccurate results, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Remel Inc is recalling 237 single bottles of Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Reference R30164201 ZH01. The product is used in slide agglutination tests to presumptively identify Shigella cultures for epidemiological and diagnostic purposes.
The recall was initiated because the serum may fail to agglutinate within the specified minimum reaction time. This defect could result in inaccurate test results. The affected units were distributed nationwide in the United States.
The recall includes specific kit and bottle lot numbers, including Kit lot #1465529 with Bottle lot #1465528, and several other combinations involving Bottle lot #1847290 and Bottle lot #1738565. Users should check their inventory against these lot numbers and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
- Manufacturer
- Remel Inc
- Affected units
- 237
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 (15)
- UDI 50560805009592. Kit lot #1465529
- Bottle lot #1465528
- Kit lot #2118879
- Bottle lot #1847290
- Kit lot #2173683
- Kit lot #2161363
- Kit lot #1984639
- Kit lot #1738564
- Bottle lot#1738565
- Kit lot #1971308
- Bottle lot #1738565
- Kit lot #1957305
- Kit lot #1947930
- and Kit lot #1847285
- Bottle lot #1738565.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Remel Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighStrep Selective II Agar plates may carry Listeria monocytogenes contamination
FDA (Devices) · 2025-08-06
Same hazard · inaccurate diagnostic result
See all →- HighSiemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
FDA (Devices) · 2020-10-28
- ModerateBinding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
FDA (Devices) · 2020-03-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
- HighAbbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
FDA (Devices) · 2019-03-13
Similar recalls
- HighRemel Bordetella pertussis Agglutinating Serum Recalled for False Negative Results
FDA (Devices) · 2020-09-09
- ModerateRemel Thioglycollate Medium Recalled for Performance Testing Failures
FDA (Devices) · 2018-09-19
- HighOxoid Agglutinating Sera Salmonella 9-0 Serotyping Classification Error
FDA (Devices) · 2026-04-29
- HighRemel Blood Agar Plates Recalled for Listeria monocytogenes Contamination
FDA (Devices) · 2015-06-17
- ModerateRemel Recalls Oxoid Nitrocefin In Vitro Diagnostic Reagents
FDA (Devices) · 2016-06-15
- HighRemel Recalls PathoDx Strep Grouping Kits Due to Reagent Issues
FDA (Devices) · 2015-08-19