Z-1447-2012

ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated...

Name: Z-1447-2012 ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated...
Creator: Abbott Laboratories Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-06-30 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Inc. began a recall of ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate... on 2008-06-30. The reason FDA records is "This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases...". 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-1447-2012
Status: Terminated
Initiated: 2008-06-30
Posted: 2012-04-23
Terminated: 2012-04-23
Recalling firm: Abbott Medical
Product: ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Reason for recall: This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases the following errors may be generated. -ARCHITECT cSystems: Error Code 1053 (Unable to calculate result, rate reaction linearity failure) -AEROSET: RL% Error Code Revised P
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Laboratories sent a Product Correction letter dated August 5, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Update your assay parameters for A-AST 1. Follow the steps in the appropriate attachment: - Use Attachment A for ARCHITECT cSystems - Use Attachment B for AEROSET. 2. All A-AST results of less than (<) 5 U/L should be evaluated by comparing to other clinically relevant assays Retain a copy of this letter for your laboratory records. For questions regarding this recall call 626-440-0705.
Quantity in commerce: 1,646
Distribution: Worldwide Distribution including Germany
Product codes and lots: List Numbers 8L91-20: 57028HW00, 59035HW00, 61031HW00, 64052HW00; List Numbers 8L91-40: 57017HW00, 59031HW00, 61038HW00, 64050HW00

Product code CIT

K071525Class IIActivated Aspartate AminotransferaseAbbott Laboratories / cleared 2008-03-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)