AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL
FDA device recall Z-2317-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
- Action taken
- Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1,965 kits
- Distribution
- Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.
- Date initiated
- 2009-02-18
- Date posted
- 2009-09-30
- Date terminated
- 2010-07-08
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |