Recall Z-0653-2014— Alere San Diego, Inc.

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2013-06-03, terminated 2014-03-18. FDA's recall record names no specific 510(k) clearance for this event. 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 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: 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..

Recalling firm

Alere San Diego, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-06-03

Terminated

2014-03-18

Firm location

San Diego, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.