Alere Triage TOX Drug Screen Recalled for False Negative PCP Results
Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.
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 device with a performance defect (false negatives) that poses a risk of harm by potentially leading to incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, specifically Lots W56013B and W56035B. The recall involves 305 kits, consisting of 239 kits of Lot W56013B and 66 kits of Lot W56035B. Each kit contains 25 individually pouched devices.
The recall was initiated because Alere's investigation determined that these specific lots have a frequency of false negative results for Phencyclidine (PCP) that is higher than the frequency described in the product's package insert. The Alere Triage TOX Drug Screen is a fluorescence immunoassay used with Alere Triage Meters to qualitatively determine the presence of various drugs and metabolites in urine.
The affected products were distributed nationwide in the United States and internationally to Taiwan. Users of these specific lots should be aware that the test may fail to detect PCP at the rates indicated in the documentation.
The recalled product
- Product
- Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere…
- Manufacturer
- Alere San Diego, Inc.
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)
- Catalog Number 94400
- Lots W56013B and W56035B
Distribution
Distributed nationwide across the United States.
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