iChem Velocity recallZ-0913-2020 · Beckman Coulter Inc. · initiated Oct 28, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Software in the Use Environment
What the company is doing
An Urgent Medical Device Recall letter was sent during the week of 10/28/2019 to the affected customers via mail and e-mail. The notice stated the misidentification issue as follows: 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)." The following actions were provided to reduce the potential for this issue until a software update is available: - Follow good laboratory practice (GLP) and ensure that a unique identification system is in place. - Ensure that specimens are labeled with a unique Specimen ID and manual orders utilize a unique Specimen ID. - Do not reuse barcode number that identify different specimens. If barcode numbers must be reused, ensure results have been released from the LIS and the instrument Work List has been cleared. - Clear all manual Orders immediately after results are released, even if barcodes are used for subsequent runs (see iQ200 or iChemVELOCITY IFU, Chaper 7, Manual Orders).
Recall details
- Recall number
- Z-0913-2020
- Status
- Terminated
- Initiated by the company
- Oct 28, 2019
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 4314 devices
- Product code
- KQO
- FDA submissions
- K101852
- Distribution
- Worldwide distributions.
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.
Code information (models, lots, serial numbers)
UDI: 10837461009375, 10837461001751; All Part Numbers
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- iChem Velocity Back-Integrated Velocity (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall15 reports
- iChem Velocity Elite/Stand-Alone Velocity (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84577).
- Z-0914-2020 · TerminatediQ200 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, 7…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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