Sekisui Diagnostics recall
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human…
Why was Sekisui Diagnostics recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 120827, exp 11/27/2012
- Product
- Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human…
- Recalling firm
- Sekisui Diagnostics Llc
- Quantity
- 63 kits
- Distribution
- Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
- Recall date
- December 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)