CD123 — Class II medical device recall Z-1375-2015
Terminated recall by BD Biosciences, Systems & Reagents, reported 2015-04-08, distributed in AZ, GA, MO, NE, TX, VA. One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an
| Recall number | Z-1375-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-02-26 |
| Distributed | AZ, GA, MO, NE, TX, VA |
| Quantity | 9 |
| Lot numbers | 5008762 |
| Model numbers | 649453 |
| Expiration dates | 2016-11-30 |
Product
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1375-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.