Z-1676-2015Class III

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA

Name: Z-1676-2015 D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA
Creator: Biocare Medical, LLC
Published: 2015-05-06
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2015-05-06 / Terminated / root cause: labeling and UDI

FDA source

Biocare Medical, LLC began a recall of D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is... on 2015-05-06. FDA classified it as Class III and gives the reason as "Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1676-2015
Classification: Class III
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-05-26
Terminated: 2015-06-04
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Root cause tag: labeling and UDI
FDA 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 in commerce: 19 units
Distribution: Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
Product codes and lots: Catalog number: PM266AA, lot 030615, Expiration: 2018/03.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)