Recall Z-0547-2020 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Vital Scientific N.V.
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
| Date | Nov 15, 2018 |
| Status | Open, Classified |
| Reason | During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report. |
| Root cause | Nonconforming Material/Component |
| Action | On November 15, 2018 the firm sent an Urgent Field safety Notice via E-Mail to all affected consignees. The firm also sent out an updated notifications on November 30, 2018 and January 8, 2019 The customer notification addressed the problem and the conditions in which the problem could happen. the urgent field safety notice asked customers to do follow: 1.ELITechGroup is working with the highest priority on a permanent solution to this problem. Pending this permanent fix, we are requesting your cooperation to carry out this mandatory instruction for each active analyzer used. 2.To guarantee |
| Quantity | 732 instruments |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA Vital Scientific N.V., Mar 13, 1998 |