| Z-0008-06 |
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Reason: Device has incorrect notation associated with therapeutic drug monitoring assays.
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2005-02-28 |
Terminated
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| Z-0010-06 |
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Reason: Software deficiency causing potential shift in absorbance readings for test results.
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2005-09-14 |
Terminated
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| Z-0011-2018 |
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
Reason: There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
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2015-01-15 |
Terminated
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| Z-0016-05 |
AEROSET Analyzer, Systems Operation Manual.
Reason: Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
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2004-09-24 |
Terminated
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| Z-0020-2014 |
Clinical Chemistry Phosphorus Reagent
The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Reason: Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
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2013-08-12 |
Terminated
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