Recall Z-1000-2015— BD Biosciences, Systems & Reagents

Name: FDA recall Z-1000-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2014-12-19, terminated 2016-02-23. It names one FDA 510(k) clearance: K904390. Product: CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.. Reason: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data..

Recalling firm: BD Biosciences, Systems & Reagents
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2016-02-23
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K904390 — ANTI-HUMAN LEU-2A (CD8) PEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1990-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

Reason for recall

One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

Data sourced from openFDA. This site is unofficial and independent of the FDA.