FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0189-2012
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
- Status
- Terminated
- Initiated
- 2011-10-03
- Posted
- 2011-11-16
- Terminated
- 2012-05-11
- 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.
- Lot, serial or model codes
- Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)
- 510(k) numbers
- ["K981918"]
- PMA numbers
- not on file
- Product code
- CDQ
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28