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

FDA device recall Z-0653-2014 · posted 2014-01-09 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

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.

Action taken

Firm sent customers notification letter via combination of fax, email or direct mail. The notification letter dated June 3, 2013, titled "URGENT PRODUCT SAFETY NOTICE", informed customers of the recall, reason for recall, product description with lot codes, potential hazard statement, customer required actions, and contact information.

Root cause

Other

Status

Terminated

Product code

DKZ

Quantity affected

280,710

Distribution

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

Date initiated

2013-06-03

Date posted

2014-01-09

Date terminated

2014-03-18

Location

San Diego, CA