Company: Abbott Point of Care Inc.
Date of Enforcement Report 2/9/2011
Class ll:
PRODUCT
i-STAT Level 2 Control Value Assignment Sheets Human Consumption. a) Abbott List Number: 06F13-01; b) Abbott List Number: 025715. Recall # Z-1020-2011.
REASON
Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.
RECALLING FIRM/MANUFACTURER
Abbott Point of Care Inc., Princeton, NJ, by letter on August 3, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8293 assignment sheets
DISTRIBUTION
Nationwide and Internationally
