Z-0653-2014Class II

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

Name: Z-0653-2014 Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device...
Creator: Alere San Diego, Inc.
Published: 2013-06-03
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-06-03 / Terminated

FDA source

Alere San Diego, Inc. began a recall of 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 2013-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0653-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-03
Posted: 2014-01-09
Terminated: 2014-03-18
Recalling firm: Alere San Diego, Inc.
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.
Product code: DKZ Enzyme Immunoassay, Amphetamine
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.
FDA 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 in commerce: 280,710
Distribution: US Distribution: including states of: AL, CA, PA, and VA.
Product codes and lots: 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, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164) DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211) DOA2100614. Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0653-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0653-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

Product code DKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)