FDA Device recall Z-1390-2016
BD-Retic-Count Reticulocyte Reagent System
- FDA Device
- Class III
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class III recall of BD-Retic-Count Reticulocyte Reagent System by Becton Dickinson And Bd Biosciences, citing the carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-18 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | CA, CT, DC, FL, IN, MA, MN, NY, UT, VA |
Product
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Reason
The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.
Identifiers
| code_info | Product number 349214, Lot number 5175559, Expiry 5/31/16. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2016%22
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