Recall Z-1320-2018 ยท GIF Diluent, Blood Cell
Mindray DS USA, Inc. dba Mindray North America
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.
| Date | Jan 24, 2018 |
| Status | Terminated |
| 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. |
| 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 | 4838 |
| Distribution | US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.