Company: Roche Diagnostics Corp.
Date of Enforcement Report:2/1/06
Class:II
PRODUCT
a) Roche brand Accu-Chek Aviva Care Kit;
Catalog number 04528280001. (Distributed
within the U.S.), Recall # Z-0417-06;
b) Roche brand Accu-Chek Aviva Meter Only Kit;
Catalog number 04532279001. (Distributed
within the U.S.), Recall # Z-0418-06;
c) Roche brand Accu-Chek Aviva Bonus Pack;
Catalog number 04528247001. (Distributed
within the U.S.), Recall # Z-0419-06;
d) Roche brand Accu-Chek Aviva Retail
Distributor Pack; Catalog number 04578198001.
(Distributed within the U.S.),
Recall # Z-0420-06;
e) Roche brand Accu-Chek Aviva Bonus Pack
Display; Catalog number 045659066001.
(Distributed within the U.S.)
Recall # Z-0421-06;
f) Roche brand Accu-Chek Aviva Pediatrics Kit;
Catalog number 04593839001. (Distributed
within the U.S.) Recall # Z-0422-06;
g) Roche brand Accu-Chek Aviva Meter (mg/dL);
Catalog number 03532275001. (Distributed
within the U.S.) Recall # Z-0423-06;
h) Roche brand Accu-Chek Aviva Care Kit;
Catalog number 04422058170; – Canada
Catalog number 04422058164; – Nordics
Catalog number 04422040170. (Distributed
outside of the U.S.) Recall # Z-0424-06;
i) Roche brand Accu-Chek Aviva Meter (mg/dL);
Catalog number 03532356001. (Distributed
outside of the U.S.) Recall # Z-0425-06;
j) Roche brand Accu-Chek Aviva Meter (mmol/L);
Catalog numbers 03532313001 and 03532321001.
(Distributed outside of the U.S.)
Recall # Z-0426-06
REASON
Incorrect patient blood glucose test results may be reported due to a software problem.
CODE
a), b), c), d),e), f), g), Aviva meter serial
numbers 52500000000 through 52510999999;
h), i) and j) Aviva meter serial numbers
52600000000 through 52610999999, 52700000000
through 52710999999 and 52800000000 through
52810999999
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letters dated November 9, 2005 and press release issued on January 17, 2006.
Manufacturer: Sanmina SCI, Huntsville, AL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,143,155 meters
DISTRIBUTION
Nationwide and Internationally
