Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2018 - (Recall #: Z-1320-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 24, 2018

Date Posted: April 18, 2018

Recall Number: Z-1320-2018

Event ID: 79556

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.

Status: Terminated

Product Quantity: 4838

Code Information:

(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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated