FDA Device recall Z-1893-2018
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagn…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagn… by Beckman Coulter, citing A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1893-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Reason
A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.
Identifiers
| code_info | Lot #7212154 A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1893-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.