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U.S. Department of Health and Human Services

Class 2 Device Recall PICCOLO(TM)

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  Class 2 Device Recall PICCOLO(TM) see related information
Date Initiated by Firm November 16, 2009
Date Posted March 16, 2010
Recall Status1 Terminated 3 on December 14, 2010
Recall Number Z-1155-2010
Recall Event ID 53848
510(K)Number K942782  
Product Classification analyzer, chemistry, centrifugal, for clinical use - Product Code JFY
Product Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA

Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
Code Information Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010
Recalling Firm/
Manufacturer		 Abaxis Inc
3240 Whipple Rd
Union City CA 94587
For Additional Information Contact
510-675-6500
Manufacturer Reason
for Recall		 Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
FDA Determined
Cause 2		 Labeling mix-ups
Action An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.
Quantity in Commerce 1010 boxes
Distribution Worldwide distribution: USA and Canada, EU and Asia
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 = JFY and Original Applicant = ABAXIS, INC.
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