Company: Roche Diagnostics Corp
Date of Enforcement Report: 4/10/02
Class: II
PRODUCT
All DataCare Systems Software, as follows:
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.
Recall # Z-0682-2/Z-0699-2.
REASON
Potential patient/sample mismatch.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by correction notice dated November 13, 2001. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Approx. 450 installations.
DISTRIBUTION
Nationwide, Canada and the United Kingdom.
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