FDA recall Z-1520-2018

Diagnostic Hybrids, Inc. · Class III · device

Product

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Reason for recall

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.

Distribution

The product was distributed to the following countries: Singapore, Switzerland

Key facts

Status
Terminated
Initiation date
2016-10-26
Report date
2018-05-02
Termination date
2020-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2018