Diagnostic Hybrids, Inc. recalls Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone…
- Recall date
- October 26, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1520-2018
- FDA classification
- Class III
- Brand / firm
- Diagnostic Hybrids, Inc.
- Sold / distributed
- The product was distributed to the following countries: Singapore, Switzerland
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
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