—#46293

Product

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 product code: JGS — Electrode, Ion Specific, Sodium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K894914
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 104 Windsor Center Dr, East Windsor, New Jersey 08520-1407

Distribution

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.

Timeline

Recall initiated: 2006-05-24
Posted by FDA: 2006-06-22
Terminated: 2007-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.