Recall Z-1320-2018— Mindray DS USA, Inc. dba Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2018-01-24, terminated 2019-04-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-24
- Terminated
- 2019-04-19
- Firm location
- Mahwah, NJ, United States
Product description
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 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 Analyzers may cause the system to produce an elevated platelet background count.
Data sourced from openFDA. This site is unofficial and independent of the FDA.