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 | code info di |
| 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 |
|---|---|---|---|---|
| 2026-02-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Products Ltd. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2019-03-18 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2018-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics Manufacturing Limited | 0 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-09 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2017-09-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2017-08-25 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
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