Agency classClass IIOur severity:High FDA (Devices)·Z-0653-2014·Announced 2014-01-15

Alere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk

Alere is recalling specific lots of Oral Fluid Drug Screen Devices because the sponge may dislodge, creating a choking hazard.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (choking hazard) where injury has not yet been reported, fitting the criteria for a High severity score.

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…
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.

Lot numbers (20)

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

Distribution

Distributed in 4 states:

Same manufacturer · Alere San Diego, Inc.

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Same hazard · choking