Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-11-07 | Z-0999-2023 | Class III | Terminated | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IA, KY, LA, MA, MO, NC, NJ, NY, OH, TX and Puerto Rico. The countries of Brazil, China, Costa Rica, Czech Republic, France, Germany, Great Britain, Honduras, Hungary, Indonesia, Israel, Japan, Kuwait, Mexico, Netherlands, Nicaragua, Panama, Peru, Poland, Romania, San Salvador, South Africa, South Korea, Switzerland, Thailand, Turkey, Vietnam,. | 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes | clearance family |
| 2012-09-14 | Z-0429-2013 | Class III | Terminated | HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.Distribution: Nationwide Distribution | 22,954 | clearance family |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2015-05-15 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 |
| 2012-04-12 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 5 |
Similar devices
- ABX Minotrol 16 HORIBA ABX SAS
- ABX Minotrol 16 HORIBA ABX SAS
- ABX Minotrol 16 HORIBA ABX SAS
- ADVIA® 120/2120/2120i TESTpoint CSF Control Kit Siemens Healthcare Diagnostics Inc.
- ADVIA® 120/2120/2120i TESTpoint Retic High Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 120/2120/2120i TESTpoint Retic Low Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 360 Control Siemens Healthcare Diagnostics Inc.
- ADVIA® 560 Control Siemens Healthcare Diagnostics Inc.
- AQUIOS IMMUNO-TROL Cells BECKMAN COULTER IRELAND INC.
- AQUIOS IMMUNO-TROL Low Cells BECKMAN COULTER IRELAND INC.
- Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit Advanced Instruments, LLC
- Advanced Instruments GloCyte® Controls Kit Advanced Instruments, LLC
Select up to two to place side-by-side with this device.