FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0288-2008
- Recalling firm
- Abbott Laboratories Inc.
- Product
- Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2007-08-10
- Posted
- not on file
- Terminated
- 2012-04-19
- Reason
- Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.
- Root cause
- Material/Component Contamination
- Action
- An August 10, 2007, Product Correction letter was provided to all ARCHITECT cSystem and AEROSET System customers. The letter advises that changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the NIST standard 916a. Revised Bilirubin values for the calibrator lot numbers in this recall are attached to the recall notice. Six necessary actions were listed in the recall notice as: 1) Identify the lot numbers of Clinical Chemistry Bilirubin Calibrator(s) currently in use. 2) Discard the value sheet and replace with the appropriate values provided with the recall letter. 3) Enter the revised Bilirubin values. 4) Calibrate the assays. 5) Evaluate your quality control. 6) Evaluate your reference range and any shifts in patient results.
- Quantity
- 7,033 units total worldwide
- Distribution
- Worldwide: USA, Canada, Mexico, Guatemala, Puerto Rico, Germany, Hong Kong, Singapore, Australia, New Zealand, Jamaica, Venezuela, Columbia, Ecuador, Chile, Uruguay, Argentina, Brazil, Thailand, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, and El Salvador
- Lot, serial or model codes
- List Number (LN) 1E66-03 Lot Number: 38436M100 (Expires September 30, 2007); List Number (LN) 1E66-04 Lot Numbers: 41456M100 (Expires December 31, 2007), 42396M100 (Expires April 30, 2008), 48616M100 (Expires July 31, 2007)
- 510(k) numbers
- ["K981706"]
- PMA numbers
- not on file
- Product code
- JIX
- 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