Recall Z-0977-2013 ยท CFR Hexokinase, Glucose
Mindray DS USA, Inc. d.b.a. Mindray North America
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
| Date | Mar 22, 2013 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. |
| Root cause | Device Design |
| Action | Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge. |
| Quantity | 3 units |
| Distribution | Distributed in the states of NC and TX. |
| FDA record | Open on fda.gov |