FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-0913-2020
- Recalling firm
- Beckman Coulter Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-10-28
- Posted
- not on file
- Terminated
- 2026-04-01
- Reason
- 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).
- Root cause
- Software in the Use Environment
- Action
- 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).
- Quantity
- 4314 devices
- Distribution
- Worldwide distributions.
- Lot, serial or model codes
- UDI: 10837461009375, 10837461001751; All Part Numbers
- 510(k) numbers
- ["K101852"]
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28