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.
FDA Recall Z-1171-06 · Posted 2006-06-22
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeJGS
Date Initiated2006-05-24
Date Terminated2007-08-15
Product Quantity59775 cartridges
Reason for Recall
Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained
Firm Action
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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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