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U.S. Department of Health and Human Services

Class 2 Device Recall BBL DrySlide PYR kit

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 Class 2 Recall
BBL DrySlide PYR kit
see related information
Date Posted May 29, 2013
Recall Status1 Terminated on September 28, 2013
Recall Number Z-1422-2013
Recall Event ID 65089
Premarket Notification
510(K) Number
K921583 
Product Classification Discs, Strips And Reagents, Microorganism Differentiation - Product Code JTO
Product BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Code Information PYR kit - lot 2276481 with expiration date 09/30/13
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4000
Manufacturer Reason
for Recall
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inquiries to BD Technical Services at 1-800-638-8663.
Quantity in Commerce 610 total test kits (PYR and Oxidase)
Distribution Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JTO and Original Applicant = DIFCO LABORATORIES, INC.
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