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U.S. Department of Health and Human Services

Class 3 Device Recall ISTAT PORTABLE CLINICAL ANALYZER, MODEL 300

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  Class 3 Device Recall ISTAT PORTABLE CLINICAL ANALYZER, MODEL 300 see related information
Date Initiated by Firm September 09, 2009
Date Posted February 24, 2010
Recall Status1 Terminated 3 on December 08, 2014
Recall Number Z-0812-2010
Recall Event ID 53335
510(K)Number K001387  
Product Classification PORTABLE CLINICAL ANALYZER - Product Code CGA
Product i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA.

The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
Code Information Catalog number 06F16-10. 
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter Scott
609-454-9000
Manufacturer Reason
for Recall		 The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
FDA Determined
Cause 2		 Labeling mix-ups
Action An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.
Quantity in Commerce 3,918 analyzers
Distribution Worldwide Distribution (including the United States).
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 = CGA and Original Applicant = I-STAT CORP.
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