FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. 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.
- Recall number
- Z-3219-2011
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. 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.
- 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
- 138 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 103551, 110071, 110381, 110382, 110383, 110841, 110842, 110901, 110902
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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