Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues
Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential incorrect threshold settings which could lead to inaccurate test results, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Alere San Diego, Inc. is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel (P/N: 94402). The affected lots are K51245RB, W51022RB, and W51207RB. These products were distributed nationwide.
The recall is being conducted because there is a possibility that after installing the code chip provided with the affected lots for AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with Alere Triage Meters for the qualitative determination of the presence of drug and/or major metabolites in urine.
No specific instructions for consumers are provided in the source text, but the recall indicates a potential issue with the accuracy of the device's threshold settings for specific drug classes.
The recalled product
- Product
- Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended 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 concentr
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 591
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 (3)
- Lot Codes: K51245RB
- W51022RB
- W51207RB
Distribution
Distributed nationwide across the United States.
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