FDA recall, , Moderate risk
STA Liatest Free Protein S
The STA Liatest Free Protein S kit may show out-of-range results and underestimate free protein S levels in normal plasma.
Summary by Recall Canary from the FDA notice
What happened
Diagnostica Stago, Inc., of Parsippany, New Jersey, began a recall on February 4, 2026, of the STA Liatest Free Protein S kit because of 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.
The FDA added the recall to its Enforcement Report on March 3, 2026, and it was in the weekly enforcement report on March 11, 2026. The kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma. Distribution was worldwide, including US nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
STA Liatest Free Protein S
- Model number
- 00516
- UDI-DI
- 03607450005165
- Lot code
- 271
- 971
- 272
- 859
- 273
- 018
- 426
- 241001
- 260131
- 271971
- 241
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, GUATEMALA, INDIA, IRAQ, IRELAND, ITALY, JORDAN, KENYA, KOREA REPUBLIC OF, LITUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PALESTINIAN TERRITORY, PARAGUAY, PORTUGAL, ROMANIA, RUSSIE, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIE, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY;
- Company
- Diagnostica Stago, Inc.Parsippany, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98394
- Recall number
- Z-1491-2026
All recalls from Diagnostica Stago, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
