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
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling approximately 6,601 iQ200 Series Urine Microscopy Analyzer devices distributed worldwide. The devices have a reported hazard where two sets of test results can display the same Specimen Identifier but show different results, different Medical Record Numbers, and different patient identification information. This issue creates a risk that patient test results could be mismatched with the wrong patient's records.
The recall affects multiple catalog numbers and all part numbers associated with the affected UDI codes. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide distributions. Quantity: 6601 devices Lot/code info: UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.