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Terminated

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

FDA Recall Z-1520-2018 · Posted None

Recalling FirmDiagnostic Hybrids, Inc.
Recall StatusTerminated
Product CodeCEW
Date Initiated2016-10-26
Date Terminated2020-08-28
Product Quantity26

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISASangui Biotech, Inc. · 1997-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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