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U.S. Department of Health and Human Services

Class 2 Device Recall Piccolo Comprehensive Metabolic Panel

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  Class 2 Device Recall Piccolo Comprehensive Metabolic Panel see related information
Date Initiated by Firm November 19, 2010
Date Posted February 09, 2011
Recall Status1 Terminated 3 on August 23, 2011
Recall Number Z-1066-2011
Recall Event ID 57321
510(K)Number K950164  
Product Classification Nadh oxidation/nad reduction, alt/sgpt - Product Code CKA
Product Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028;
Product is manufactured and distributed by Abaxis, Incorporated,
Union City, CA

The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¿contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.
Code Information Lot Number: 0396BC5  Boxes # 686 - 834 and # 665-685.
Recalling Firm/
Manufacturer		 Abaxis, Incorporated
3240 Whipple Rd
Union City CA 94587
For Additional Information Contact Paul Bailey
510-675-6500
Manufacturer Reason
for Recall		 Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.
FDA Determined
Cause 2		 Other
Action The firm, Abaxis Inc., sent an "URGENT PRODUCT RECALL NOTICE" dated November 19, 2010, to all customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory of the lot for boxes #0665 or higher; if found, to discontinue use; contact Abaxis for immediate replacement; complete and return the enclosed PRODUCT RECALL RESPONSE form to Abaxis Technical Support via fax at 1-877-349-2087, and ensure that their laboratory staff is informed of this recall notice. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, or at medtechsupport@abaxis.com.
Quantity in Commerce 797 units
Distribution Worldwide distribution: USA and countries of: Kowloon and Germany.
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 = CKA and Original Applicant = ABAXIS, INC.
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