Becton Dickinson & Co.: 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

Recall number

Z-3218-2011

Recalling firm

Becton Dickinson & Co.

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

Status

Terminated

Initiated

2011-05-24

Posted

2011-09-16

Terminated

2011-10-12

Reason

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.

Root cause

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

163 kits

Distribution

Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

NQX

Firm FEI

1119779

Firm city

Sparks

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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