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Terminated

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.

FDA Recall Z-1066-2011 · Posted 2011-02-09

Recalling FirmAbaxis, Incorporated
Recall StatusTerminated
Product CodeCKA
Date Initiated2010-11-19
Date Terminated2011-08-23
Product Quantity797 units

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.

Firm 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 [email protected].

Root Cause

Other

Distribution Pattern

Worldwide distribution: USA and countries of: Kowloon and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORAbaxis, Inc. · 1995-04-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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