Recall Z-2287-2008
Abaxis Inc · initiated April 21, 2008
Product
Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.
Codes / lots: software version 6.121 with Electrolyte Panel Lot #8041AC5, expiration date 2009-01-21
Reason for recall
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2287-2008
- Initiated
- April 21, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- April 26, 2011
- Product code
- JLB – Atp And Creatine Kinase (Enzymatic), Creatine
- Quantity
- 237 kits
- Distribution
- Product was distributed Worldwide.
- Recalling firm
- Abaxis Inc, Union City, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2286-2008 | Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot…The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | 04/21/2008Terminated |