Recall Z-2927-2018 ยท GKR System, Hemoglobin, Automated
Siemens Healthcare Diagnostics, Inc.
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
| Date | Jul 16, 2018 |
| Status | Terminated |
| Reason | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels. |
| Root cause | Device Design |
| Action | The firm, Siemens Healthineers, sent an "Urgent Field Safety Notice" letter dated 7/2018 to its customers via FedEx on 7/18/18. The recall communication alerts customers that therapeutic levels of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas Systems identified in the letter. Customer are advised to review the letter with their Medical Director, and complete and return the effectiveness check form within 7 days. Customers may continue to use their devices. Siemens is not recommending a review of previousl |
| Quantity | 2248 |
| Distribution | Nationwide distribution. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020616 | BAYER RAPIDPOINT 405 SYSTEM Bayer Diagnostics Corp., Jul 17, 2002 |