Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
This recall has been terminated (originally issued November 16, 2011).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- October 3, 2011
- Posted
- November 16, 2011
- Terminated
- May 11, 2012
- Recall Number
- Z-0189-2012
- Quantity
- 5704 units of Urea Nitrogen
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution.
Lot / Code Info
Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)
Root Cause
Process control
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.