FDA Device

DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

Hazard

Lacks professional use labeling and firm name and address.

What You Should Do

Remedy

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.

Products

DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
Brand
Drug Free Enterprises Inc
UPC
All Codes.

Units Affected

2800 units