Home / Recalls / Clark Laboratories, Inc. (dba,Trinity Biotech USA) / Z-2782-2016

Z-2782-2016 Class III Terminated

Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) — Jamestown, NY

Recall Details

Product Type
Devices
Report Date
September 21, 2016
Initiation Date
July 11, 2016
Termination Date
May 9, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
US: 6 kits, Foreign: 50 kits

Product Description

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Reason for Recall

The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

Distribution Pattern

Distribution to US nationwide including California, and China (Hong Kong).

Code Information

Lot Number 2326060-043, Expiration Date 31 May 2017

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  • Z-0621-2019 Class II — Genesys Analytical Column, REF 01-05-0017 intended to be used with automated hig (November 1, 2018)
  • Z-0623-2019 Class II — Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high perfor (November 1, 2018)
  • Z-0622-2019 Class II — Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high perfor (November 1, 2018)
  • Z-0819-2015 Class III — Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-9 (November 17, 2014)
  • Z-0572-2014 Class II — Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for (August 27, 2013)
  • Z-2445-2012 Class III — Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2 (May 29, 2012)