Z-0463-2013Class II

Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of...

Name: Z-0463-2013 Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of...
Creator: Sekisui Diagnostics Llc
Published: 2012-10-24
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2012-10-24 / Terminated / root cause: manufacturing process

FDA source

Sekisui Diagnostics Llc began a recall of Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma... on 2012-10-24. FDA classified it as Class II and gives the reason as "Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring 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-0463-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-24
Posted: 2012-12-03
Terminated: 2013-01-08
Recalling firm: Sekisui Diagnostics, LLC
Product: Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro 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 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Sekisui Diagnostics issued an "URGENT PRODUCT RECALL NOTICE" dated October 24, 2012 to all consignees. The letter instructed consignees to immediately stop using the specified lot of product, discard any remaining inventory and return the enclosed response form. Contact the Customer Service Department at 800-637-3375, ext. 10, 12, or 31 for assistance with this recall.
Quantity in commerce: 63 kits
Distribution: Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
Product codes and lots: Lot # 120827, exp 11/27/2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0463-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

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)