Recall Z-0843-2020 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Analyzer
| Date | Nov 7, 2019 |
| Status | Terminated |
| Reason | Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results. |
| Root cause | Error in labeling |
| Action | The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letters on 11/07/2019. The letter explained the problem and how to recognize if the S3 flag has been disabled in the instrument. The letter further instructs the following: - Review results to determine if samples report an SG result of >1.060 or an SG result of S3 - If the SG result is >1.060 or S3, test samples for SG using an alternate method* determined by your laboratory - If persistent SG results are >1.060 or persistent S3 results are seen, contact your local Beckman Coulter Representative If you have any questions r |
| Quantity | 4314 units |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, France, |
| 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 |