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U.S. Department of Health and Human Services

Class 2 Device Recall Martel Printer Accessory to iSTAT Portable Clinical Analyzer

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  Class 2 Device Recall Martel Printer Accessory to iSTAT Portable Clinical Analyzer see related information
Date Initiated by Firm April 22, 2009
Date Posted September 30, 2009
Recall Status1 Terminated 3 on February 25, 2010
Recall Number Z-2328-2009
Recall Event ID 51872
510(K)Number K001387  
Product Classification Glucose Test System - Product Code CGA
Product Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack.

Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
Code Information Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with serial numbers 281071578 to 281071977; 281174571 to 281174970; 281276302 to 281276701 and 290178290 to 290178689. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008.
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
104 Windsor Center Dr
East Windsor NJ 08520
For Additional Information Contact Peter Scott
609-443-9300
Manufacturer Reason
for Recall		 It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.
Quantity in Commerce 2552
Distribution Worldwide Distribution
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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