Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Pi
FDA device recall Z-1155-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Abaxis Inc
- Reason for recall
- Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
- Action taken
- An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1010 boxes
- Distribution
- Worldwide distribution: USA and Canada, EU and Asia
- Date initiated
- 2009-11-16
- Date posted
- 2010-03-16
- Date terminated
- 2010-12-14
- Location
- Union City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PICCOLO(TM) (K942782) | Abaxis, Inc. | 1995-03-13 |