Sekisui Diagnostics — Class II medical device recall Z-0463-2013
Terminated recall by Sekisui Diagnostics Llc, reported 2012-12-12, distributed nationwide. Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing th
| Recall number | Z-0463-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sekisui Diagnostics Llc, Stamford, CT, United States |
| Recall initiated | 2012-10-24 |
| Classified | 2012-12-03 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2013-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 63 kits |
| Reason classes | potency |
| Lot numbers | 120827 |
| Model numbers | 101201 |
| Expiration dates | 2012-11-27 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0463-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.