Z-0189-2012

Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen...

Name: Z-0189-2012 Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen...
Creator: Abbott Laboratories, Inc
Published: 2011-10-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-10-03 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine on 2011-10-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0189-2012
Status: Terminated
Initiated: 2011-10-03
Posted: 2011-11-16
Terminated: 2012-05-11
Recalling firm: Abbott Medical
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.
Product code: CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 5704 units of Urea Nitrogen
Distribution: Worldwide Distribution.
Product codes and lots: Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)

Product code CDQ

K981918Class IIUreaAbbott Laboratories / cleared 1998-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)