Date of enforcement report: 2/28/01
Date of recall: 9/12/00
Company: Escreen Inc.
Class: II
PRODUCT:
EScreen System, which collectively includes the eCUP, the
eREADER optical imaging technology, and the eCUP data analysis
software, for use in drug abuse testing. Recall #Z-205-1.
REASON:
Distributed without 510(k) clearance.
CODE:
All.
MANUFACTURER:
EScreen Inc., Overland Park, KS.
RECALLED BY:
Manufacturer, by letters, dated 9/12/00. Firm-initiated recall
complete.
DISTRIBUTION:
Nationwide.
QUANTITY:
300 units.
