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U.S. Department of Health and Human Services

Class 2 Device Recall Oral Fluid Drug Screen

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  Class 2 Device Recall Oral Fluid Drug Screen see related information
Date Initiated by Firm June 03, 2013
Date Posted January 09, 2014
Recall Status1 Terminated 3 on March 18, 2014
Recall Number Z-0653-2014
Recall Event ID 66870
Product Classification Oral Fluid Drug Screen Device - Product Code DKZ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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