Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 26, 2014
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 Triage¿ Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amp
Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that thes…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alere San Diego, Inc. recalled Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W560… - a moderate-severity action.
Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W560… was recalled by Alere San Diego, Inc. in March 26, 2014. Reason: Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots…. Check the official notice for the remedy. Verify recall #Z-1214-2014 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this moderate-severity FDA Devices recall-Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots….
- Moderate
- severity level
- Class II
- classification
- March 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1214-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1214-2014) was formally reported on March 26, 2014, with the manufacturer initiating the action on February 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Alere San Diego, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 305 kits (239 kits of W56013B, 66 kits of W56035B).
The documented reason for this recall is: Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negativ… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
305 kits (239 kits of W56013B, 66 kits of W56035B)
Related Recalls
6
3 from same agency
Product description
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 Triage¿ Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
Reason for recall
Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1214-2014 |
| Date reported | March 26, 2014 |
| Date initiated | February 5, 2014 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 305 kits (239 kits of W56013B, 66 kits of W56035B) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Taiwan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1214-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Triage¿ Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.. Recalled by Alere San Diego, Inc.. Units affected: 305 kits (239 kits of W56013B, 66 kits of W56035B).
Why was this product recalled? ▼
Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1214-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1214-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 26, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.