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Terminated

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 Recall Z-1505-06 · Posted 2006-09-16

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLHJ
Date Initiated2006-08-17
Date Terminated2007-03-09
Product Quantity1,572 kits

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

Worldwide-product was sold to distributors and end users

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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