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.

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 mo…

Recall #: Z-2431-2012
Affected scope: 699 kits
Initiated: August 28, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Sekisui Diagnostics Llc recalled Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasmino… - a moderate-severity action.

Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasmino… was recalled by Sekisui Diagnostics Llc in September 26, 2012. Reason: SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This wil…. Check the official notice for the remedy. Verify recall #Z-2431-2012 with the FDA Devices before acting.

The recall

Sekisui Diagnostics Llc issued this moderate-severity FDA Devices recall-SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This wil….

Moderate
severity level: Class II
classification: September 26, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2431-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2431-2012
Date reported	September 26, 2012
Date initiated	August 28, 2012
Recalling firm	Sekisui Diagnostics Llc
Firm location	Stamford, CT
Affected scope	699 kits
Distribution	Nationwide distribution: USA including states of: FL, IN, IL, and WA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2431-2012) and product description against the item you own. Search the archive
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Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2431-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide distribution: USA including states of: FL, IN, IL, and WA..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported September 26, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026