Z-0208-04

AEROSET Phenobarbital, LN 1E08-01

Name: Z-0208-04 AEROSET Phenobarbital, LN 1E08-01
Creator: Abbott Laboratories Diagnostic Div
Published: 2003-11-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-03 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of AEROSET Phenobarbital, LN 1E08-01 on 2003-11-03. The reason FDA records is "Assay is imprecise". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0208-04
Status: Terminated
Initiated: 2003-11-03
Posted: 2004-07-20
Terminated: 2004-07-29
Recalling firm: Abbott Medical
Product: AEROSET Phenobarbital, LN 1E08-01
Product code: LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Reason for recall: Assay is imprecise.
FDA root cause: Other
Action: Firm telephoned customers on 11/3/2003 and followed up with a letter offering credit or replacement.
Quantity in commerce: 112
Distribution: Nationwide, Mexico, England and Canada
Product codes and lots: Lots: 01066HW00 expires 10/31/2003 06030HW00 expires 4/30/2004 08060HW00 expires 7/31/2004

Product code LGQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)