Home / Recalls / Sekisui Diagnostics Llc / Z-2431-2012

Z-2431-2012 Class II Terminated

Recalled by Sekisui Diagnostics Llc — Stamford, CT

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
August 28, 2012
Termination Date
July 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
699 kits

Product Description

Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.

Reason for Recall

SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.

Distribution Pattern

Nationwide distribution: USA including states of: FL, IN, IL, and WA.

Code Information

Lot Numbers: 120425 and 120601

Other recalls by Sekisui Diagnostics Llc

  • Z-0015-2014 Class II — Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United (September 16, 2013)
  • Z-0463-2013 Class II — Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantita (October 24, 2012)
  • Z-1902-2012 Class II — MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Ass (May 29, 2012)