Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 15, 2014
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be pre
Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the or…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alere San Diego, Inc. recalled Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Dr… - a moderate-severity action.
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Dr… was recalled by Alere San Diego, Inc. in January 15, 2014. Reason: Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may becom…. Check the official notice for the remedy. Verify recall #Z-0653-2014 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this moderate-severity FDA Devices recall-Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may becom….
- Moderate
- severity level
- 281K units
- affected scope
- Class II
- classification
- January 15, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0653-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0653-2014) was formally reported on January 15, 2014, with the manufacturer initiating the action on June 3, 2013. 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 280,710, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If t… Distribution data in the federal record shows the product reached: US Distribution: including states of: AL, CA, PA, and VA.. 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
280,710
Related Recalls
6
3 from same agency
Product description
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.
Reason for recall
Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0653-2014 |
| Date reported | January 15, 2014 |
| Date initiated | June 3, 2013 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 280,710 |
| Distribution | US Distribution: including states of: AL, CA, PA, and VA. |
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-0653-2014) 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): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.. Recalled by Alere San Diego, Inc.. Units affected: 280,710.
Why was this product recalled? ▼
Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0653-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution: including states of: AL, CA, PA, and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0653-2014) 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 January 15, 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.