Z-0803-03

Aeroset Direct HDL Reagent, LN 7D67-01

Name: Z-0803-03 Aeroset Direct HDL Reagent, LN 7D67-01
Creator: Abbott Laboratories Diagnostic Div
Published: 2003-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-03-28 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of Aeroset Direct HDL Reagent, LN 7D67-01 on 2003-03-28. The reason FDA records is "Degredation prior to expiry date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0803-03
Status: Terminated
Initiated: 2003-03-28
Posted: 2003-05-09
Terminated: 2004-09-16
Recalling firm: Abbott Medical
Product: Aeroset Direct HDL Reagent, LN 7D67-01
Reason for recall: Degredation prior to expiry date.
FDA root cause: Other
Action: Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.
Quantity in commerce: 1409
Distribution: Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.
Product codes and lots: Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003

K981580Class IHdlAbbott Laboratories / cleared 1998-06-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)