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U.S. Department of Health and Human Services

Class 2 Device Recall BD ProbeTec" CT/GC/AC Reagent Pack

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  Class 2 Device Recall BD ProbeTec" CT/GC/AC Reagent Pack see related information
Date Initiated by Firm September 29, 2010
Date Posted June 24, 2011
Recall Status1 Terminated 3 on June 24, 2011
Recall Number Z-2658-2011
Recall Event ID 58875
510(K)Number K984631  
Product Classification DNA probe, nucleic acid amplification, chlamydia - Product Code MKZ
Product BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***

The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.
Code Information Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011
Recalling Firm/
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kim Cartier
Manufacturer Reason
for Recall
In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.
FDA Determined
Cause 2
Process control
Action BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated September 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and discard any remaining product. BD will replace any discarded products. Additionally, customers were requested to complete and return an attached form whether or not they have any inventory remaining, to confirm receipt of the notification. The letter instructed the customers to fax the completed form to: Attention: Regulatory Compliance at 410-316-4258. For assistance regarding replacements, contact BD Customer Service Department at 1-800-675-0908. All other inquiries should contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 130 kits
Distribution Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.
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.
510(K) Database 510(K)s with Product Code = MKZ and Original Applicant = BECTON DICKINSON MICROBIOLOGY SYSTEMS