Home / Recalls / Diagnostic Hybrids, Inc. / Z-1499-2018

Z-1499-2018 Class III Terminated

Recalled by Diagnostic Hybrids, Inc. — Athens, OH

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
November 3, 2015
Termination Date
August 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 kits

Product Description

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Reason for Recall

A component of the kit was found to contain bacterial contamination.

Distribution Pattern

Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

Code Information

Lot 052419

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-1520-2018 Class III — Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quant (October 26, 2016)
  • 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-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)