DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
FDA device recall Z-0239-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- Drug Free Enterprises Inc
- Reason for recall
- Lacks professional use labeling and firm name and address.
- Action taken
- Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- DIO
- Quantity affected
- 2800 units
- Distribution
- Nationwide.
- Date initiated
- 2003-03-20
- Date posted
- 2003-12-18
- Date terminated
- 2003-12-17
- Location
- Agoura Hills, CA
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