Remel Inc Recalls Streptex Kits Due to Potential False Negative Results
Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.
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 is classified as FDA Class II, and the hazard involves a risk of harm (false negative results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Remel Inc is recalling 768 units of the Streptex kit, Reference R30950501 ZL50, a rapid latex test system used for the qualitative detection and identification of the Lancefield group of streptococci. The affected product is identified by Lot 1192181 with an expiration date of January 2014. The kits were distributed nationwide.
The recall was initiated because the product may give weak or false negative test results. The Streptex kit contains reagents for groups A, B, C, D, F, and G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England.
Healthcare professionals and laboratories should stop using the affected kits and contact Remel Inc for further instructions. Consumers are not directly affected as this is an in-vitro diagnostic (IVD) product intended for professional use.
The recalled product
- Product
- Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test…
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 768
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 1192181
- 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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