Reported Jun 25, 2025 · Ongoing

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent…

Diagnostica Stago, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607

Is this the product you have?

  • STA - Owren Koller
  • Model/Catalog Number00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families
Lot codes and dates
  • UDI(01)13607450003601(11)240331(17)260331(10)270902(241)00360
  • Lot Number270902
Amount recalled
939 US ( 2,810 total worldwide)

Where it was sold

Why it was recalled

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.