medical Class II Updated 2020-02-05

Beckman Coulter Inc. recalls iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 70

Recalled 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.


Hazard / Issue

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).

Issued by

FDA

Distribution: Worldwide distributions.
Lot/Code Info: UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers
View official government recall

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