Company: Roche Diagnostics Corp
Date of Enforcement Report: 5/1/02
Class: II
PRODUCT
All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2.
a) DataCare ABG Data Management System for use in a blood gas
point of care testing environment; Catalog GD9200;
b) DataCare ABG Data Management System for use in a blood gas
point of care testing environment; Catalog GD9201;
c) DataCare ABG Data Management System for use in a blood gas
point of care testing environment; Catalog BP9251;
d) DataCare ABG Data Management System for use in a blood gas
point of care testing environment; Catalog BP9252;
e) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog GD9200;
f) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog GD9201;
g) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog GD9206;
h) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog GD9207;
i) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog GD9208;
j) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog BP9251;
k) DataCare POC Data Management System for use in a blood gas,
glucose and coagulation point of care testing environment;
Catalog BP9252;
l) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog GD9202;
m) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog GD9209;
n) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog GD9010;
o) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog GD9211;
p) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog GD9212
q) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog BP9215;
r) DataCare GM Data Management System for use in a glucose only
point of care testing environment; Catalog BP9216.
REASON
Potential patient/sample mismatch.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by urgent product correction dated April 15, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Approx. 512 installations.
DISTRIBUTION
Nationwide, the United Kingdom and Canada.
