FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD AffirM VPIII Microbial Identification Test
- Recall number
- Z-1394-2017
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD AffirM VPIII Microbial Identification Test
- Status
- Terminated
- Initiated
- 2015-08-27
- Posted
- 2017-02-27
- Terminated
- 2017-03-06
- Reason
- BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
- Root cause
- Employee error
- Action
- Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663. For further questions please call (410) 316-4428.
- Quantity
- Qty Distributed to Field - 4,502
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
- Lot, serial or model codes
- Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648
- 510(k) numbers
- ["K931374"]
- PMA numbers
- not on file
- Product code
- MLA
- 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