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U.S. Department of Health and Human Services

Class 2 Device Recall Fuso Analyzer 300F

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  Class 2 Device Recall Fuso Analyzer 300F see related information
Date Initiated by Firm September 08, 2011
Date Posted July 09, 2012
Recall Status1 Terminated 3 on January 28, 2013
Recall Number Z-1975-2012
Recall Event ID 62319
510(K)Number K001387  
Product Classification Glucose oxidase, glucose - Product Code CHL
Product Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540

Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
Code Information FUSO Analyzer 300F  310003 All lots 
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Mr. Larry W. Krasley
609-454-9272
Manufacturer Reason
for Recall		 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
FDA Determined
Cause 2		 Device Design
Action Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.
Quantity in Commerce 310003 -2203 units
Distribution Worldwide Distribution - USA (nationwide)
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 = CHL and Original Applicant = I-STAT CORP.
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