FDA Device recall Z-0653-2014
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Devic…
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Devic… by Alere San Diego, citing 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 or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0653-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-03 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | AL, CA, PA, VA |
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.
Identifiers
| code_info | Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099) DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA30…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0653-2014%22
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