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Terminated

Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.

FDA Recall Z-0189-2012 · Posted 2011-11-16

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeCDQ
Date Initiated2011-10-03
Date Terminated2012-05-11
Product Quantity5704 units of 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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981918UREAAbbott Laboratories · 1998-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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