Company: Roche Diagnostics Corp
Date of Enforcement Report: 2/6/02
Class: II
PRODUCT
All DataCare Systems Software, as follows:
A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S.
B) DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201. Dist. in U.S.
C) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment); Catalog BP9251;
D) DataCare Networked Client Kit for customer that includes manual and
software (sent in conjunction with DataCare Networked Client Computer for
DataCare ABG Data Management System for use in a blood gas point of care
testing environment; Catalog BP9252;
E) DataCare Server/Workstation Computer for DataCare POC Software Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200. Dist. in U.S., Canada and the United Kingdom;
F) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201. Dist. in U.S., Canada and the United Kingdom;
G) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206. Dist. U.S., Canada and the United Kingdom;
H) DataCare Power Class Server Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207. Dist. U.S., Canada and the United Kingdom;
I) DataCare Laptop Computer for DataCare POC Data Management System for
use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208. Dist. U.S., Canada and the United Kingdom;
J) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251. Dist. U.S., Canada and the United Kingdom;
K) DataCare Networked Client Kit for customer that includes manual and software (sent in conjuction with DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252. Dist. U.S., Canada and the United Kingdom;
L) DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202. Dist. U.S.;
M) DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209. Dist. U.S.;
N) DataCare Server Class Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9210. Dist. U.S.;
O) DataCare Power Class Server Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211. Dist. U.S.;
P) DataCare Laptop Computer for DataCare GM Data Management System for
use in a glucose only point of care testing environment; Catalog GD9212. Dist. U.S.;
Q) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment); Catalog BP9215. Dist. U.S.;
R) DataCare Networked Client Kit for customer that includes manual and software for use in conjunction with DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216; Dist. U.S.
Recall # Z-0517-02.
REASON
Possible sample results mismatch with patient information.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated Dec. 28, 2001. Manufacturer: Roche Diagnostics Corp., Roswell, GA.Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Approx. 450 installations.
DISTRIBUTION
Nationwide, Canada and the United Kingdom.
