Z-1505-06

BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit)...

Name: Z-1505-06 BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit)...
Creator: Becton Dickinson & Co.
Published: 2006-08-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2006-08-17 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents... on 2006-08-17. The reason FDA records is "False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1505-06
Status: Terminated
Initiated: 2006-08-17
Posted: 2006-09-16
Terminated: 2007-03-09
Recalling firm: Becton Dickinson & Co
Product: BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.
Product code: LHJ Staphylococcus Aureus Protein A Insoluble
Reason for recall: False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.
FDA root cause: Other
Action: The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06.
Quantity in commerce: 1,572 kits
Distribution: Worldwide-product was sold to distributors and end users
Product codes and lots: Lot Number / Exp. Date 16629910 April 30, 2007-Cat # 240952 16562410 April 30, 2007-Cat # 240952 16629920 April 30, 2007-Cat # 240953 16562420 April 30, 2007-Cat # 240953

Product code LHJ

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)