Recall Z-1893-2018 ยท LJX Test, Urine Leukocyte
Beckman Coulter Inc.
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 i
| Date | Dec 4, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | The firm initiated the recall by letter on 12/04/2017. The letter identified the affected product, problem and the actions to be taken. The firm requested destruction of the recalled product. |
| Quantity | 14340 units |
| Distribution | Worldwide Distribution and US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT Iris International Inc., A Division of Iris Iris I, Mar 23, 2011 |