Recall Z-1066-2011 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Abaxis, Incorporated
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 t
| Date | Feb 9, 2011 (initiated Nov 19, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Reca |
| Quantity | 797 units |
| Distribution | Worldwide distribution: USA and countries of: Kowloon and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR Abaxis, Inc., Apr 13, 1995 |