FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Aeroset Direct HDL Reagent, LN 7D67-01
- Recall number
- Z-0803-03
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Aeroset Direct HDL Reagent, LN 7D67-01
- Status
- Terminated
- Initiated
- 2003-03-28
- Posted
- 2003-05-09
- Terminated
- 2004-09-16
- Reason
- Degredation prior to expiry date.
- Root cause
- Other
- Action
- Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.
- Quantity
- 1409
- Distribution
- Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.
- Lot, serial or model codes
- Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003
- 510(k) numbers
- ["K981580"]
- PMA numbers
- not on file
- Product code
- not on file
- 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