Recall Z-0864-2020 ยท OUG Medical Device Data System
Radiometer Medical ApS
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
| Date | Aug 8, 2019 |
| Status | Terminated |
| Reason | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up. |
| Root cause | Software design |
| Action | On 07/15/2019, the firm, Radiometer America, Inc., sent an "Urgent: Medical Device Correction" to customers via FedEx with tracking and email to inform them that the firm has become aware that there is a potential problem related to its system that may result in patient mix-up when connected to some third-party devices. This recall affects all system below version 2.3.5. On September 24th, the firm sent a updated letter via email which updated that only 7 third party devices could be potentially affected (Originally 10 third party devices). The firm is instructing customers to: If the cust |
| Quantity | 947 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of: Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.