FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
- Recall number
- Z-1400-05
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
- Status
- Terminated
- Initiated
- 2005-08-05
- Posted
- 2005-08-24
- Terminated
- 2012-03-07
- Reason
- The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
- Root cause
- Other
- Action
- A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.
- Quantity
- 213
- Distribution
- Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
- Lot, serial or model codes
- List # 1E66-03; Lot #20881M100
- 510(k) numbers
- not on file
- 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