Z-1559-2008

BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part...

Name: Z-1559-2008 BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part...
Creator: BD Diagnostic Systems / Lee Laboratories
Published: 2007-09-06
License: https://open.fda.gov/license/

Lee Laboratories, Inc. / initiated 2007-09-06 / Terminated

FDA source

BD Diagnostic Systems / Lee Laboratories began a recall of BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton... on 2007-09-06. The reason FDA records is "Exhibits cross reactivity with Neisseria meningitides Group W135". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1559-2008
Status: Terminated
Initiated: 2007-09-06
Posted: 2008-08-08
Terminated: 2009-03-24
Recalling firm: Lee Laboratories, Inc.
Product: BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
Product code: GTJ Antisera, All Groups, N. Meningitidis
Reason for recall: Exhibits cross reactivity with Neisseria meningitides Group W135.
FDA root cause: Mixed-up of materials/components
Action: BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
Quantity in commerce: 500 units
Distribution: Worldwide Distribution --- including USA and country of New Zealand.
Product codes and lots: Lot #6311396, EXP 2009-09-19

Product code GTJ

K844407Class IIDirectigen Neissena Menningitidis Group B TestBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1985-01-25

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)