Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil
FDA device recall Z-2287-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Abaxis Inc
- Reason for recall
- The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JLB
- Quantity affected
- 237 kits
- Distribution
- Product was distributed Worldwide.
- Date initiated
- 2008-04-21
- Date posted
- 2008-09-17
- Date terminated
- 2011-04-26
- Location
- Union City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PICCOLO METLYTE 7 REAGENT DISC (K992140) | Abaxis, Inc. | 1999-08-26 |