Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0914-2020 — 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 urin

U.S. FDA — Device Enforcement · United States · 2019-10-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0914-2020
Date of alert
2019-10-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10837461001317
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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