FDA Medical Device Recalls (openFDA)
Diagnostic Hybrids, Inc.: Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
- Recall number
- Z-1520-2018
- Recalling firm
- Diagnostic Hybrids, Inc.
- Product
- Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
- Status
- Terminated
- Initiated
- 2016-10-26
- Posted
- not on file
- Terminated
- 2020-08-28
- 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
- Lot, serial or model codes
- Lot 068259
- 510(k) numbers
- ["K974306"]
- PMA numbers
- not on file
- Product code
- CEW
- Firm FEI
- 1000122536
- Firm city
- Athens
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28