Company: Bayer Corporation
Date of Enforcement Report: 3/27/02
Class: III

PRODUCT
Clinitek 100 Software Kit. Recall # Z-0634-2.

REASON
False negative results when high concentrations of ketone exist.

CODE
Version 7.00.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Corp., Elkhart, IN, by telephone and fax on January 21, 2002.
Manufacturer: Bayer Corporation, Mishawaka, IN.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5.

DISTRIBUTION
CT, MD, MA, NY and TX.