Date Initiated by Firm |
January 24, 2018 |
Create Date |
April 09, 2018 |
Recall Status1 |
Terminated 3 on April 19, 2019 |
Recall Number |
Z-1321-2018 |
Recall Event ID |
79556 |
Product Classification |
Diluent, blood cell - Product Code GIF
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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. |
Code Information |
Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302 |
Recalling Firm/ Manufacturer |
Mindray DS USA, Inc. dba Mindray North America 800 Macarthur Blvd Mahwah NJ 07430-2001
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For Additional Information Contact |
Diane Arpino 201-995-8407
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Manufacturer 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.
|
FDA Determined Cause 2 |
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. . |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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