Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human ser
FDA device recall Z-0189-2012 · posted 2011-11-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.
- Action taken
- The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CDQ
- Quantity affected
- 5704 units of Urea Nitrogen
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-10-03
- Date posted
- 2011-11-16
- Date terminated
- 2012-05-11
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UREA (K981918) | Abbott Laboratories | 1998-07-28 |