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.
What this means for you
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.
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