FDA Medical Device Recalls (openFDA)
Abaxis Inc: 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.
- Recall number
- Z-2286-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-04-21
- Posted
- 2008-09-17
- Terminated
- 2011-04-26
- Reason
- The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
- 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
- 893 kits
- Distribution
- Product was distributed Worldwide.
- Lot, serial or model codes
- software version 6.121 with Comprrehensive Metabolic Lot #8111AA5, expiration date 2009-03-10
- 510(k) numbers
- ["K992140"]
- PMA numbers
- not on file
- Product code
- JLB
- Firm FEI
- 2939693
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28