Z-0321-05

BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)

Name: Z-0321-05 BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
Creator: BD Diagnostic Systems
Published: 2004-10-20
License: https://open.fda.gov/license/

Lee Laboratories, Inc. / initiated 2004-10-20 / Terminated

FDA source

BD Diagnostic Systems began a recall of BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19) on 2004-10-20. The reason FDA records is "Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0321-05
Status: Terminated
Initiated: 2004-10-20
Posted: 2004-12-16
Terminated: 2005-02-01
Recalling firm: Lee Laboratories, Inc.
Product: BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
Product code: GSY Antisera, Fluorescent, All Globulins, Proteus Spp.
Reason for recall: Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
FDA root cause: Other
Action: Consignees were notified by letter beginning 10/20/2004.
Quantity in commerce: 100 vials (5ml per vial)
Distribution: Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
Product codes and lots: Catalogue #240490, Lot #3079439

Product code GSY

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)