FDA Device recall Z-1000-2015
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046
- FDA Device
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046 by Bd Biosciences Systems And Reagents, citing one lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1000-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bd Biosciences Systems And Reagents |
| Distribution | US |
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.
Identifiers
| code_info | Lot number 4220622, Expiry 2016-04-30. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1000-2015%22
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