Date Initiated by Firm |
May 24, 2006 |
Date Posted |
June 22, 2006 |
Recall Status1 |
Terminated 3 on August 15, 2007 |
Recall Number |
Z-1171-06 |
Recall Event ID |
35513 |
510(K)Number |
K894914
|
Product Classification |
Blood Gas Panel reagents - Product Code JGS
|
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. |
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. |
Recalling Firm/ Manufacturer |
Abbott Laboratories 104 Windsor Center Dr East Windsor NJ 08520-1407
|
For Additional Information Contact |
J. 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 |
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.
|
Quantity in Commerce |
59775 cartridges |
Distribution |
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.
|
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = JGS and Original Applicant = I-STAT CORP.
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