FDA Device recall Z-1001-2020
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075 by Clinical Diagnostic Solutions, citing A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-02 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Clinical Diagnostic Solutions |
| Distribution | US |
Product
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Reason
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Identifiers
| code_info | Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.