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CLOTtrac™
MEDTRONIC, INC. · Model 550-01 · UDI-DI 00763000558185
1
510(k) clearances
7,801
Adverse events (39 deaths)
43
Recalls
39
Facilities
Description
CONTROL 550-01 CLOTTRAC CWB
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-21 | Diagnostica Stago, Inc. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of |
| 2022-04-26 | Haemonetics Corporation | Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in compa |
| 2022-04-19 | Haemonetics Corporation | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP |
| 2021-03-02 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| 2020-11-09 | Helena Laboratories, Corp. | Due to complaints received associated with cracked/split test tube caps. |
| 2020-02-19 | Haemonetics Corporation | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG |
| 2019-07-23 | Instrumentation Laboratory Co. | Prolonged clotting times |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.