BD-Retic-Count Reticulocyte Reagent System — Class III medical device recall Z-1390-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-04-20, distributed in CA, CT, DC, FL, IN, MA, MN, NY…. The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage condition
| Recall number | Z-1390-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2016-03-18 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-12-02 |
| Distributed | CA, CT, DC, FL, IN, MA, MN, NY, UT, VA |
| Countries outside the US | BE, BR, CA, CN, IN, JP, KR, SG, TW |
| Quantity | 205 |
| Reason classes | labeling |
| Lot numbers | 5175559 |
| Expiration dates | 2016-05-31 |
Product
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Reason for recall
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.
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-1390-2016. 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.