Recall Z-2936-2020 ยท MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Diasorin Inc.
Parvovirus B19 IgG EIA kit Part No. V519IGUS
| Date | Jul 17, 2020 |
| Status | Open, Classified |
| Reason | Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value |
| Root cause | Under Investigation by firm |
| Action | DiaSorin issued a customer notification letter on July 17, 2020. The letter states the following action to be taken: Please use the Lot Specific Constant value of 0.14 with your remaining inventory of Lot 71440040AA.. The Lot Specific Constant is used to calculate the cut-off value and use of the incorrect value may lead to: 1. An invalid test due to the Low Positive Control resulting above the upper limit of the assigned range. 2. The reporting of a false positive patient result if the Low Positive Control does not fail and invalidate the test run. If you have used the affected product |
| Quantity | 615 units |
| Distribution | NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.