Alere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy
Alere San Diego is recalling 9,997 Triage Tox+MTD Drug Screen kits because they may produce false positive or negative results due to decreased precision and accuracy.
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 product (medical diagnostic) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Alere San Diego, Inc. is recalling 9,997 units of the Alere Triage Tox+MTD Drug Screen (PN 94400). The recall was initiated because the company confirmed that the product may have significantly decreased precision and accuracy compared to its claimed specifications.
The affected drug screen kits are used with Alere Triage Meters to qualitatively determine the presence of various drugs and metabolites in urine. The recall is due to an observed increased frequency of false positive and/or false negative results. The affected lots are W50216B, W50222B, W50245B, W50250B, W50809B, W50810B, W50812B, W50813B, W50816B, W50817B, W50818B, W50819B, W50820B, W50821B, W50822B, W50823B, W50826B, W50829B, W50830B, W50831B, W50832B, W50837B, W50838B, W50842B, W50843B, W50844B, W50846B, W50848B, W50851B, W50862B, W50866B, W50869B, W50870B, W50871B, W50872B, and W50873B.
The product was distributed nationwide in the United States. Users should check their inventory for the affected lot codes and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 9,997
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 (20)
- Lot/Unit Codes: W50216B
- W50222B
- W50245B
- W50250B
- W50809B
- W50810B
- W50812B
- W50813B
- W50816B
- W50817B
- W50818B
- W50819B
- W50820B
- W50821B
- W50822B
- W50823B
- W50826B
- W50829B
- W50830B
- W50831B
Distribution
Distributed nationwide across the United States.
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