Recall Z-0463-2013
Sekisui Diagnostics Llc · initiated October 24, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot # 120827, exp 11/27/2012
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0463-2013
- Initiated
- October 24, 2012
- Posted by FDA
- December 3, 2012
- Terminated
- January 8, 2013
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Quantity
- 63 kits
- Distribution
- Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
- Recalling firm
- Sekisui Diagnostics Llc, Stamford, CT