Escreen No 510(k) Class II

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.