Remel Recalls PathoDx Strep Grouping Kits Due to Reagent Issues
Remel Inc is recalling 1,859 PathoDx Strep Grouping Kits because a reagent may cause weak reactions, potentially leading to failure to identify target species.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (diagnostic failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Remel Inc is voluntarily recalling 1,859 units of the PathoDx Strep Grouping Kit, REF 62025. The product is a latex agglutination test used to identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F, or G from primary culture plates. The affected lot is 1470133, with an expiration date of March 31, 2016.
The recall was initiated because a reagent present in the kit may produce weak or slow reactions. Continued use of the product may result in a failure to identify the target species, which could impact diagnostic accuracy.
The product was distributed nationwide, including Puerto Rico and Canada. Users should stop using the affected kits and contact Remel Inc for further instructions or a refund.
The recalled product
- Product
- PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
- Manufacturer
- Remel Inc
- Affected units
- 1,859
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 1470133
- exp. date 31 Mar 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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