—#48291

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.

FDA product code: LHJ — Staphylococcus Aureus Protein A Insoluble
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide-product was sold to distributors and end users

Timeline

Recall initiated: 2006-08-17
Posted by FDA: 2006-09-16
Terminated: 2007-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.