Recalls / —
—#179967
Product
iChemVELOCITY Strips, Catalog 800-7212
- FDA product code
- KQO — Automated Urinalysis System
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K101852
- Affected lot / code info
- Catalog 800-7212, UDI 10837461002628; Lot 7212269M
Why it was recalled
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter, Inc.
- Address
- 11800 SW 147th Ave, Miami, Florida 33196-2500
Distribution
- Distribution pattern
- Distribution in US including Puerto Rico, Canada, and Taiwan
Timeline
- Recall initiated
- 2020-02-17
- Terminated
- 2021-05-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179967. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.