Food, drugs, devices › Biocare Medical, LLC
Device recall: D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mo
Biocare Medical, LLC (Concord, CA) initiated this device recall on 6 May 2015; FDA lists 1 product record under event 71229, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 4 Jun 2015. Initiation: voluntary: firm initiated. Biocare Medical, LLC has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Biocare Medical, LLC, Concord, CA.
Reason for recall
"Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40."
Distribution
"Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1676-2015 | 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… | 19 units | Class III | Terminated | 3 Jun 2015 |
Context
Other enforcement events for Biocare Medical, LLC
All 10 events for Biocare Medical, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.