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Recall Observatory FDA recall evidence

Device product

iQ200 Series Urine Microscopy Analyzer- All part numbers

Z-1945-2020

March 30, 2020

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 85423
Status
Terminated
Classification
Class II
Quantity
3576 units
Official record key
device-enforcement:Z-1945-2020

Official wording

Reason: A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

Code information: Catalog Numbers: 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, C10684., All part numbers

Distribution pattern: US Distribution: Nationwide Foreign Distribution: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.