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Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Scree...

FDA Device Recall #Z-0653-2014 — Class II — June 3, 2013

Recall Summary

Recall Number Z-0653-2014
Classification Class II — Moderate risk
Date Initiated June 3, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alere San Diego, Inc.
Location San Diego, CA
Product Type Devices
Quantity 280,710

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.

Distribution Pattern

US Distribution: including states of: AL, CA, PA, and VA.

Lot / Code Information

Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099)  DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420. DSD-765-011 (Alere PN 4080350099)  DOA2100672, DOA2120094, DOA2120095, DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565, DOA3020557. DSF-765-031 (Alere PN 4584150099)  DOA2100438, DOA2100667, DOA2110073, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164)  DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211)  DOA2100614. Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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