Recall Z-0038-2020 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Vital Scientific N.V.
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
| Date | Sep 7, 2018 |
| Status | Terminated |
| Reason | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification. |
| Root cause | Device Design |
| Action | On 9/7/2018, a "Medical Device Recall" notice was sent to consignees. The recall notification, informed customers of the following: 1. ELITechGroup B.V. is requesting to correct this issue during the next preventive maintenance visit to your end user. The fix must be applied by a certified service engineer. No spare parts or special tooling is required to fix this issue. When done, this will be the long-term solution. See document 3084-249-00 Instructions Cooling indicator board for the detailed instructions. 2. Short term actions: ELITechGroup B.V. has already amended the applicable assembl |
| Quantity | 192 devices |
| Distribution | US Nationwide distribution including the state of New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.