Recall Z-0653-2014 ยท DKZ Enzyme Immunoassay, Amphetamine
Alere San Diego, Inc.
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/
| Date | Jan 9, 2014 (initiated Jun 3, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 280,710 |
| Distribution | US Distribution: including states of: AL, CA, PA, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.