Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
This recall has been terminated (originally issued October 26, 2016).
- Company
- Diagnostic Hybrids, Inc.
- Recall Initiated
- October 26, 2016
- Terminated
- August 28, 2020
- Recall Number
- Z-1520-2018
- Quantity
- 26
- Firm Location
- Athens, OH
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot 068259
Root Cause
Nonconforming Material/Component
Action Taken
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.
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