| Class 2 Device Recall Piccolo Comprehensive Metabolic Panel | |
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
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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 selfcontained 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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CKA
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