Product Brand Name(s): Innovacon Oral Fluid Drug Screen recall
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO…
Why was Product Brand Name(s): Innovacon Oral Fluid Drug Screen recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 280,710
- Distribution
- US Distribution: including states of: AL, CA, PA, and VA.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)