iChem Velocity recallZ-1535-2020 · Beckman Coulter, Inc. · initiated Feb 17, 2020
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
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.
Recall details
- Recall number
- Z-1535-2020
- Status
- Terminated
- Initiated by the company
- Feb 17, 2020
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 10822 vials
- Product code
- KQO
- FDA submissions
- K101852
- Distribution
- Distribution in US including Puerto Rico, Canada, and Taiwan
Product description
iChemVELOCITY Strips, Catalog 800-7212
Code information (models, lots, serial numbers)
Catalog 800-7212, UDI 10837461002628; Lot 7212269M
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- iChem® VELOCITY™ iChem VELOCITY Urine Chemistry StripsBeckman Coulter Ireland Inc. · Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1 recall0 reports
Product lines
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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