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Recall Observatory FDA recall evidence

Device product

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

Z-0914-2020

October 28, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 84577
Status
Terminated
Classification
Class II
Quantity
6601 devices
Official record key
device-enforcement:Z-0914-2020

Official wording

Reason: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

Code information: UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers

Distribution pattern: Worldwide distributions.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).