Device Recall DIASTAT AntiCCP test kit

The kit lots have the following lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09);and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8¿C. The nonconforming kit compoinent is the Negative Control (labeled ''CONTROL --''). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).

Immunology and Microbiology Devices

2

No

Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India.

Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)