Recall Z-1520-2018 ยท CEW Radioimmunoassay, Parathyroid Hormone
Diagnostic Hybrids, Inc.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
| Date | Oct 26, 2016 |
| Status | Terminated |
| Reason | There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified via letter and email on 10/26/16. Customers were asked to complete and return the attached response form to the recalling firm. Customers were asked to review inventory, quarantine the products with the specified lot numbers, and, if further distributed, identify and notify any additional customers. |
| Quantity | 26 |
| Distribution | The product was distributed to the following countries: Singapore, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA Sangui Biotech, Inc., Dec 23, 1997 |