Recall Z-1937-2019 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
| Date | Oct 18, 2018 |
| Status | Terminated |
| Reason | Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction. |
| Root cause | Component change control |
| Action | The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue. |
| Quantity | 956,798/100 test strip vials |
| Distribution | Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan. |
| 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 |