| 2021-10-15 |
Class II
|
Terminated |
Z-0274-2022 |
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAP… |
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Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and cali… |
| 2021-05-20 |
Class II
|
Terminated |
Z-2030-2021 |
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas … |
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The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| 2020-11-18 |
Class II
|
Terminated |
Z-0943-2021 |
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A |
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Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned v… |
| 2020-04-09 |
Class II
|
Terminated |
Z-2071-2020 |
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Cli… |
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A software issue that may affect the analyzer's result accuracy. |