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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm July 21, 2003
Date Posted August 20, 2003
Recall Status1 Terminated 3 on November 19, 2003
Recall Number Z-1094-03
Recall Event ID 26884
510(K)Number k984631  
Product Classification Dna-Reagents, Neisseria - Product Code LSL
Product Becton Dickinson's ProbeTec (tm) ET Instrument
Code Information Instrument serial numbers 1001-2056
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Circle
Sparks MD 21152
For Additional Information Contact Charlotte Duke
Manufacturer Reason
for Recall
Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
FDA Determined
Cause 2
Action The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.
Quantity in Commerce 1015 units
Distribution Product was distributed to domestic and military end users nationwide and international distributors.
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 = LSL and Original Applicant = BECTON DICKINSON MICROBIOLOGY SYSTEMS