Home / Recalls / Diagnostic Hybrids, Inc. / Z-1520-2018

Z-1520-2018 Class III Terminated

Recalled by Diagnostic Hybrids, Inc. — Athens, OH

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
October 26, 2016
Termination Date
August 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26

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.

Distribution Pattern

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

Code Information

Lot 068259

Other recalls by Diagnostic Hybrids, Inc.

  • Z-1496-2018 Class II — MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of ci (April 4, 2017)
  • Z-1797-2018 Class II — MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific a (July 14, 2016)
  • Z-1497-2018 Class III — MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of c (November 3, 2015)
  • Z-1499-2018 Class III — MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the qu (November 3, 2015)
  • Z-1498-2018 Class III — MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An (November 3, 2015)
  • Z-0417-2015 Class II — MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components (October 16, 2014)
  • Z-0792-2013 Class III — Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075 (December 31, 2012)