Alere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk

Plain-English summary

Alere San Diego, Inc. is recalling specific lots of Innovacon, OrALert, Reditest On-Site, and XALEX Oral Fluid Drug Screen Devices. The recall involves 280,710 units distributed in Alabama, California, Pennsylvania, and Virginia. The affected products are packaged in kits of 25 individually pouched test devices and collectors.

The recall was initiated because the sponge in the Saliva Collector handle may become dislodged prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during specimen collection, the donor may inadvertently swallow it, which presents a choking risk.

Consumers and healthcare providers should stop using the affected lots immediately. The specific lot codes and expiration dates (ranging from 10/31/14 to 2/28/15) are listed in the official recall notice. Users should contact Alere for instructions on returning or disposing of the recalled products.

The recalled product

Product

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 po

Manufacturer

Alere San Diego, Inc.

Category

Medical Device — Diagnostic Test

Hazard

• choking

Affected units

280,710

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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