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.
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 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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