FDA Device

i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02.

Hazard

Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained

What You Should Do

Remedy

Recall letters were sent out via federal express and email notification was sent electronically with instructions as attachments during the period of 5/8/2006 through 6/7/2006 to include stop useage, and hold for replacement.

Products

i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catal
Brand
Abbott Laboratories
UPC
Lot Number -- Expiration Date:  U06024B -- exp. date 09/14/06; U06037C -- exp. date 09/28/06; U06062A -- exp. date 10/28/06; U06063 -- exp. date 10/28/06.

Units Affected

59775 cartridges