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Class 2 Device Recall BD BBL Staphyloslide Latex Test Kit |
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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
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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
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For Additional Information Contact |
Regulatory Compliance 800-638-8663
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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.
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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
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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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