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.
FDA Recall Z-3220-2011 · Posted 2011-09-16
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeNQX
Date Initiated2011-05-24
Date Terminated2011-10-12
Product Quantity61 kits
Reason for Recall
Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.