Z-2286-2008

Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number...

Name: Z-2286-2008 Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number...
Creator: Abaxis Inc
Published: 2008-04-21
License: https://open.fda.gov/license/

Abaxis Inc / initiated 2008-04-21 / Terminated / root cause: manufacturing process

FDA source

Abaxis Inc began a recall of Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive... on 2008-04-21. The reason FDA records is "The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2286-2008
Status: Terminated
Initiated: 2008-04-21
Posted: 2008-09-17
Terminated: 2011-04-26
Recalling firm: Abaxis Inc
Product: Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.
Product code: JLB Atp And Creatine Kinase (Enzymatic), Creatine
Reason for recall: The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issued a notification letter to its consignees on April 21, 2008. The firm intends to follow up with phone calls and provide a software upgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.
Quantity in commerce: 893 kits
Distribution: Product was distributed Worldwide.
Product codes and lots: software version 6.121 with Comprrehensive Metabolic Lot #8111AA5, expiration date 2009-03-10

Product code JLB

K992140Class IPiccolo Metlyte 7 Reagent DiscAbaxis, Inc. / cleared 1999-08-26

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)