Z-1155-2010

Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry...

Name: Z-1155-2010 Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry...
Creator: Abaxis Inc
Published: 2009-11-16
License: https://open.fda.gov/license/

Abaxis Inc / initiated 2009-11-16 / Terminated / root cause: labeling and UDI

FDA source

Abaxis Inc began a recall of Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog... on 2009-11-16. The reason FDA records is "Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1155-2010
Status: Terminated
Initiated: 2009-11-16
Posted: 2010-03-16
Terminated: 2010-12-14
Recalling firm: Abaxis Inc
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.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
Root cause tag: labeling and UDI
FDA 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 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 [email protected].
Quantity in commerce: 1010 boxes
Distribution: Worldwide distribution: USA and Canada, EU and Asia
Product codes and lots: Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010

Product code JFY

K942782Class IPiccolo(tm)Abaxis, Inc. / cleared 1995-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)