Biosite Inc Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
Brand
Biosite Inc
Lot Codes / Batch Numbers
Lot/Unit Codes: 186625
Products Sold
Lot/Unit Codes: 186625
Biosite Inc is recalling Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitati due to The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result
Recommended Action
Per FDA guidance
Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026