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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Staphyloslide Latex Test Kit

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  Class 2 Device Recall BD BBL Staphyloslide Latex Test Kit see related information
Date Initiated by Firm August 17, 2006
Date Posted September 16, 2006
Recall Status1 Terminated 3 on March 09, 2007
Recall Number Z-1505-06
Recall Event ID 35794
Product Classification Staphyloslide Latex Test Kit - Product Code LHJ
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.
Code Information 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
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Regulatory Compliance
800-638-8663
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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