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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX GBS

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  Class 2 Device Recall BD MAX GBS see related information
Date Initiated by Firm May 24, 2011
Date Posted September 16, 2011
Recall Status1 Terminated 3 on October 12, 2011
Recall Number Z-3220-2011
Recall Event ID 59359
Product Classification System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
Product BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours.

The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.
Code Information Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact John R. Gerlich
410-316-4000
Manufacturer Reason
for Recall		 Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.
Quantity in Commerce 61 kits
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
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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