Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Ab
FDA device recall Z-0301-2008 · posted 2008-01-04 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
- Action taken
- This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 302 units
- Distribution
- Worldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Austr
- Date initiated
- 2007-07-25
- Date posted
- 2008-01-04
- Date terminated
- 2009-11-17
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |