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.
Recall
- Recall Number
- Z-1171-06
- Event Number
- 35513
- Firm
- Abbott Laboratories
- FEI Number
- 2245578
- Product Code
- JGS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 24, 2006
- Posted
- June 22, 2006
- Terminated
- August 15, 2007
- Address
- 104 Windsor Center Dr, East Windsor, NJ, 08520-1407
Description
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.
Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained
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.
World wide ---There is only one US customer for these lots. The rest are international customers (Germany, Turkey, Hong Kong, Japan, Canada). There are no government accounts.
59775 cartridges