Lower riskMedical device recall · FDA · Published February 4, 2026
Stago STA Liatest Free Protein S: Risk of inaccurate test results
Diagnostica Stago recalls STA Liatest Free Protein S kits (model 00516) due to potential out-of-range results and underestimation of free protein S levels in patient plasmas. Affected kits may give incorrect readings for normal-range values.
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Take action
Contact the company
📍Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607
✎ GovInfoNow plain-language explainer
Diagnostica Stago is recalling its STA Liatest Free Protein S test kits (model 00516) because they might produce inaccurate results for free protein S levels in patient plasmas. This could lead to incorrect medical decisions if used without the recall fix. Read more at govinfonow.com/recall/50052-stago-sta-liatest-free-protein-s-risk-of-inaccurate-test.
“Stago STA Liatest Free Protein S: Risk of inaccurate test results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50052-stago-sta-liatest-free-protein-s-risk-of-inaccurate-test. Based on FDA recall #Z-1491-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1491-2026%22&limit=1).
The FDA announced on Feb. 4, 2026, that Diagnostica Stago, Inc. is recalling STA Liatest Free Protein S kits due to the potential for out-of-range results and underestimation of free protein S levels in normal patient plasmas. The agency issued recall number Z-1491-2026 for the Class II device.
How to tell if you have it
Brand: Stago
Product Name: STA Liatest Free Protein S
Model/Catalog Number (REF): 00516
UPC: 03607450005165
Lot numbers: 271 971, 272 859, 273 018, 273 426
The hazard
The kits may produce out-of-range results and underestimate free protein S levels in normal patient plasmas. The defect specifically affects normal-range values.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since Oct. 25, 2017. Other recent recalls of similar products include the STA Staclot Protein S Recall (July 29, 2026), the STA Liatest D-Di recall (Feb. 5, 2026), and the Asserachrom HPIA Kit Recall (Dec. 15, 2025).
How to tell if you have this one
Check for model number 00516 on the kit packaging. Affected kits have lot numbers 271971, 272859, 273018, or 273426.
Brand
Stago
Product
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for model number 00516 and lot numbers 271971, 272859, 273018, or 273426 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1491-2026 (February 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1491-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.