FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: 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
- Recall number
- Z-1447-2012
- Recalling firm
- Abbott Laboratories Inc.
- 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
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2012-04-23
- Terminated
- 2012-04-23
- Reason
- 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
- 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
- 1,646
- Distribution
- Worldwide Distribution including Germany
- Lot, serial or model codes
- List Numbers 8L91-20: 57028HW00, 59035HW00, 61031HW00, 64052HW00; List Numbers 8L91-40: 57017HW00, 59031HW00, 61038HW00, 64050HW00
- 510(k) numbers
- ["K071525"]
- PMA numbers
- not on file
- Product code
- CIT
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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