FDAFDA · Food and drugs·Recall number Z-1320-2018
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.
Published April 18, 2018 · Recall initiated: January 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
- Lot
- (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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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