Device product
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Z-1520-2018
Product summary
- Event
- Event 79595
- Status
- Terminated
- Classification
- Class III
- Quantity
- 26
- Official record key
device-enforcement:Z-1520-2018
Official wording
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.
Code information: Lot 068259
Distribution pattern: The product was distributed to the following countries: Singapore, Switzerland
Derived failure modes
-
Unknown
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.