FDA Device recall Z-1320-2018
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer by Mindray Ds Usa, citing certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1320-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-24 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mindray Ds Usa |
| Distribution | CA, MI, NC, PR, TX, WA |
Product
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.
Reason
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.
Identifiers
| code_info | (1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112…(1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112901, 2016060401, 2016052701, 2016052101, 2016050301; (2)105-005406-00 (20L container) Lot Numbers: 2017041104, 2016121901, 2016051801, 2016050301 |
|---|
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-1320-2018%22
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