FDA Device recall Z-1375-2015
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent by Bd Biosciences Systems And Reagents, citing one lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1375-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bd Biosciences Systems And Reagents |
| Distribution | AZ, GA, MO, NE, TX, VA |
Product
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Reason
One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.
Identifiers
| code_info | Lot 5008762, Exp 11/30/16. |
|---|
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-1375-2015%22
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