Z-1362-2018 Class II Terminated
FDA device recall Z-1362-2018 was initiated by Beckman Coulter Inc. on Mar 2, 2018 and is designated Class II. Reason for recall: Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but… The recall status is terminated (terminated Jul 6, 2023). Affected quantity: 5247 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Mar 2, 2018
- Termination Date
- Jul 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5247 units
Product Description
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
Reason for Recall
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
Distribution Pattern
Worldwide
Code Information
All
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1362-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026