| 2023-09-29 |
Class II
|
Ongoing |
Z-0326-2024 |
Alinity c Iron Reagent, Reference Number 08P3920 |
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A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples re… |
| 2023-09-29 |
Class II
|
Ongoing |
Z-0325-2024 |
IRON assay, Reference Numbers 6K95-41 and 6K95-30 |
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A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples re… |
| 2021-07-29 |
Class III
|
Terminated |
Z-0033-2022 |
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the… |
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Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loa… |
| 2021-04-30 |
Class III
|
Ongoing |
Z-2012-2021 |
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 16670… |
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Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provid… |