Recall Z-0189-2012 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Abbott Laboratories, Inc
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
| Date | Nov 16, 2011 (initiated Oct 3, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 5704 units of Urea Nitrogen |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981918 | UREA Abbott Laboratories, Jul 28, 1998 |