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.
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 2/5 (Moderate).
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…
- 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.
Related recalls
Same manufacturer · Alere San Diego, Inc.
See all →- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
FDA (Devices) · 2026-10-07
- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighAbbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
FDA (Devices) · 2024-05-08
Same hazard · mis calibration
See all →- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModeratePhilips Ingenia Elition S MRI stiffness value error correction
FDA (Devices) · 2026-05-06
- ModeratePhilips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
FDA (Devices) · 2026-05-06
- ModeratePhilips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
FDA (Devices) · 2026-05-06
- ModeratePhilips Evolution 3.0T MR Elastography upgrade stiffness calculation error
FDA (Devices) · 2026-05-06
Similar recalls
- HighAlere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy
FDA (Devices) · 2012-07-25
- ModerateAlere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes
FDA (Devices) · 2012-10-17
- HighAlere Triage TOX Drug Screen Recalled for False Negative PCP Results
FDA (Devices) · 2014-03-26
- LowAlere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure
FDA (Devices) · 2013-10-30
- ModerateAlere Triage Total 5 Control Level 1 Recalled for Incorrect Ranges
FDA (Devices) · 2016-11-23
- SevereAlere Triage Cardiac Panel Recalled for Decreased Precision
FDA (Devices) · 2012-07-18