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Terminated

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.

FDA Recall Z-0463-2013 · Posted 2012-12-03

Recalling FirmSekisui Diagnostics Llc
Recall StatusTerminated
Product CodeGGP
Date Initiated2012-10-24
Date Terminated2013-01-08
Product Quantity63 kits

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063323SPECTROLYSE PAI-1, MODEL 101201American Diagnostica, Inc. · 2007-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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