Z-2431-2012Class II

Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator...

Name: Z-2431-2012 Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator...
Creator: Sekisui Diagnostics Llc
Published: 2012-08-28
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2012-08-28 / Terminated / root cause: manufacturing process

FDA source

Sekisui Diagnostics Llc began a recall of Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma... on 2012-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2431-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-09-20
Terminated: 2016-07-25
Recalling firm: Sekisui Diagnostics, LLC
Product: 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.
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at [email protected].
Quantity in commerce: 699 kits
Distribution: Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Product codes and lots: Lot Numbers: 120425 and 120601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2431-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2431-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code GGP

K063323Class IISpectrolyse Pai-1, Model 101201American Diagnostica, Inc. / cleared 2007-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)