FDAFDA · Food and drugs·Recall number Z-0913-2020
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
Published February 5, 2020 · Recall initiated: October 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide distributions.
- Lot
- UDI: 10837461009375, 10837461001751; All Part Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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