Alere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure
Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The defect affects quality control monitoring but does not impact patient results or test devices.
Plain-English summary
Alere San Diego, Inc. has initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (Part Number 94413, Lot Number C2681A). The recall is due to a defect in the CODE CHIP provided with this specific lot, which causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screen products.
The affected product is a quality control material consisting of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. It is intended to be used with Alere Triage TOX Drug Screen tests and meters to assist laboratories in monitoring test performance. The recall covers 38 units distributed nationwide in the USA, as well as in South Africa and Canada.
The Alere Triage TOX Drug Screen test devices and patient results are not affected by this recall. Laboratories using this specific lot of control material should stop using it and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 38
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 (1)
- Part Number 94413. Lot Number C2681A.
Distribution
Distributed nationwide across the United States.
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