Z-0801-03

Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott...

Name: Z-0801-03 Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-04-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-04-07 / Terminated

FDA source

Abbott Laboratories HPD/ADD began a recall of Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 on 2003-04-07. The reason FDA records is "Particulate matter in the microparticle component". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0801-03
Status: Terminated
Initiated: 2003-04-07
Posted: 2003-05-09
Terminated: 2003-08-19
Recalling firm: Abbott Medical
Product: Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Product code: LOM--
Reason for recall: Particulate matter in the microparticle component.
FDA root cause: Other
Action: Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining.
Quantity in commerce: 289 kits
Distribution: Canada, Germany and Japan
Product codes and lots: List 7C18-25, lot 95305M200

Product code LOM--

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)