Z-1321-2018Class II

Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container)...

Name: Z-1321-2018 Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container)...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2018-01-24
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2018-01-24 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of 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... on 2018-01-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1321-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-24
Posted: 2018-04-09
Terminated: 2019-04-19
Recalling firm: Datascope Corp.
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.
Product code: GIF Diluent, Blood Cell
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Letters dated January 24, 2018, were sent to consignees with the following instructions: The issue manifests intermittently, therefore, you may continue to use affected lots if the background check is successfully completed. Discard affected lots which cause the system to display the error message background abnormal. Mindray will replace the potentially affected lots at no cost. Please contact Technical Support to order replacement product. For further questions, please call (201) 995-8407.
Quantity in commerce: 496
Distribution: US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Product codes and lots: Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1320-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-09
Z-1321-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-09

Product code GIF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)