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U.S. Department of Health and Human Services

Class 2 Device Recall i STAT

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 Class 2 Device Recall i STATsee related information
Date Initiated by FirmMay 24, 2006
Date PostedJune 22, 2006
Recall Status1 Terminated 3 on August 15, 2007
Recall NumberZ-1171-06
Recall Event ID 35513
510(K)NumberK894914 
Product Classification Blood Gas Panel reagents - Product Code JGS
Producti-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.
Code Information 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.
FEI Number 2245578
Recalling Firm/
Manufacturer		 Abbott Laboratories
104 Windsor Center Dr
East Windsor NJ 08520-1407
For Additional Information ContactJ. Scott House
609-469-0346
Manufacturer Reason
for Recall		Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained
FDA Determined
Cause 2		Other
ActionRecall 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.
Quantity in Commerce59775 cartridges
DistributionWorld 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JGS
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