Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results
Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.
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 3/5 (High).
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 involves a medical diagnostic device that may produce false negative results, posing a risk of harm through misdiagnosis, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Remel Inc. is voluntarily recalling 109 kits of Streptex Latex D, a rapid latex test system used for the qualitative detection and identification of Lancefield group streptococci. The specific product affected is Ref R30950901 ZL54, Lot 1149576, with an expiration date of January 2014. The product was distributed nationwide.
The recall was initiated because the product may give weak or false negative test results. This hazard could lead to incorrect clinical interpretations regarding the presence of streptococcal group D.
Healthcare facilities and laboratories that have purchased this specific lot of Streptex Latex D should stop using the product and contact Remel Inc. for instructions on return or replacement.
The recalled product
- Product
- Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative…
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 109
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 1149576
- exp January 2014
Distribution
Distributed nationwide across the United States.
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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