Recall Z-3218-2011

Becton Dickinson & Co. · initiated May 24, 2011

Terminated

Product

BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. 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. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits

Codes / lots: Lot numbers 103362, 103551, 103552, 110071, 110072, 110101, 110191, 110281, 110321, 110381, 110561, 110562, 110563, 110771, 110772, 110901, 111111

Reason for recall

Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient.

FDA-determined cause: Nonconforming Material/Component

Action taken

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.

Details

Recall number
Z-3218-2011
Initiated
May 24, 2011
Posted by FDA
September 16, 2011
Terminated
October 12, 2011
Product code
NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Quantity
163 kits
Distribution
Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
Recalling firm
Becton Dickinson & Co., Sparks, MD

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3216-2011 BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… 05/24/2011Terminated
Z-3217-2011 BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… 05/24/2011Terminated
Z-3219-2011 BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… 05/24/2011Terminated
Z-3220-2011 BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX…Medical device bar code reader does not function as intended and could result in associating clinical test… 05/24/2011Terminated