Sekisui Spectrolyse PAI-1 — Class II medical device recall Z-2431-2012
Terminated recall by Sekisui Diagnostics Llc, reported 2012-09-26, distributed nationwide. SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will
| Recall number | Z-2431-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sekisui Diagnostics Llc, Stamford, CT, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2016-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 699 kits |
| Reason classes | potency |
| Lot numbers | 120425, 120601 |
| Model numbers | 101201 |
Product
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Reason for recall
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make 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-2431-2012. 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.