Z-0913-2020 Class II Terminated
FDA device recall Z-0913-2020 was initiated by Beckman Coulter Inc. on October 28, 2019 and is designated Class II. 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 identi… The recall status is terminated (terminated April 1, 2026). Affected quantity: 4314 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- October 28, 2019
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4314 devices
Product Description
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.
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 Pattern
Worldwide distributions.
Code Information
UDI: 10837461009375, 10837461001751; All Part Numbers