Remel Recalls PathoDx Strep B Grouping Latex Reagent
Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.
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 potential failure to identify target species without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Remel Inc is recalling PathoDx Strep B Grouping Latex, REF 62031, lot 1463129, with an expiration date of 31 May 2016. The product consists of 3 ml latex reagent packaged in a plastic dropper bottle with a pink cap, used to identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F, and G from primary culture plates.
The recall was initiated because a reagent present in the product may produce weak or slow reactions. Continued use of the affected product may result in a failure to identify the target species.
A total of 4,420 bottles were distributed nationwide, including Puerto Rico and Canada. Users should stop using the product and contact Remel Inc for further instructions.
The recalled product
- Product
- PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
- Manufacturer
- Remel Inc
- Affected units
- 4,420
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 (2)
- lot 1463129
- exp. date 31 May 2016
Distribution
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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