Recall Z-2287-2008 ยท JLB Atp And Creatine Kinase (Enzymatic), Creatine
Abaxis Inc
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.
| Date | Sep 17, 2008 (initiated Apr 21, 2008) |
| Status | Terminated |
| 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 | 237 kits |
| Distribution | Product was distributed Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992140 | PICCOLO METLYTE 7 REAGENT DISC Abaxis, Inc., Aug 26, 1999 |