FDA Medical Device Recalls (openFDA)
Biocare Medical, LLC: D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
- Recall number
- Z-1676-2015
- Recalling firm
- Biocare Medical, LLC
- Product
- D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
- Status
- Terminated
- Initiated
- 2015-05-06
- Posted
- 2015-05-26
- Terminated
- 2015-06-04
- Reason
- Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
- Root cause
- Labeling mix-ups
- Action
- Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form.
- Quantity
- 19 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
- Lot, serial or model codes
- Catalog number: PM266AA, lot 030615, Expiration: 2018/03.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3004140393
- Firm city
- Concord
- Firm state
- CA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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