FDA recall Z-1321-2018

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.

Reason for recall

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.

Distribution

US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .

Key facts

Status
Terminated
Initiation date
2018-01-24
Report date
2018-04-18
Termination date
2019-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2018