Recall Z-1155-2010 ยท JFY Enzymatic Method, Creatinine
Abaxis Inc
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, chlori
| Date | Mar 16, 2010 (initiated Nov 16, 2009) |
| Status | Terminated |
| Reason | Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results. |
| Root cause | 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 |
| Quantity | 1010 boxes |
| Distribution | Worldwide distribution: USA and Canada, EU and Asia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942782 | PICCOLO(TM) Abaxis, Inc., Mar 13, 1995 |