| 2025-11-05 |
Class II
|
Ongoing |
Z-0880-2026 |
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who… |
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Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not … |
| 2025-10-21 |
Class III
|
Ongoing |
Z-0500-2026 |
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl… |
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Due to an device without a premarket clearance being incorrectly package and distributed. |
| 2024-12-02 |
Class II
|
Ongoing |
Z-0961-2025 |
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 |
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Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior … |
| 2024-09-27 |
Class II
|
Completed |
Z-0279-2025 |
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. |
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Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen lev… |
| 2022-03-30 |
Class II
|
Terminated |
Z-1121-2022 |
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block… |
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Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without U… |