Recall Z-1520-2018— Diagnostic Hybrids, Inc.

Name: FDA recall Z-1520-2018
Creator: U.S. Food and Drug Administration
Published: 2016-10-26

Class III · Terminated

Class III FDA medical device recall by Diagnostic Hybrids, Inc., initiated 2016-10-26, terminated 2020-08-28. It names one FDA 510(k) clearance: K974306. Product: Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.. 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..

Recalling firm: Diagnostic Hybrids, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-10-26
Terminated: 2020-08-28
Firm location: Athens, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K974306 — SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISASangui Biotech, Inc.·cleared 1997-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.