Diagnostica Stago Recalls STA Liatest Free Protein S Kits for Inaccurate Test Results
Diagnostica Stago, Inc. is recalling 369 units of STA Liatest Free Protein S kits due to a defect that may cause underestimation of protein S levels in normal patient plasmas.
What Happened
Diagnostica Stago, Inc. has initiated a voluntary Class II recall of its STA Liatest Free Protein S kits. The recall was prompted by the discovery of a defect that may cause out-of-range results and an underestimation of free protein S levels in normal patient plasmas. According to the firm, this issue specifically impacts values within the normal range.
Which Products Are Affected
The recall affects the STA Liatest Free Protein S kits, which are intended for use on STA-R and STA Compact systems for the quantitative antigenic assay of free protein S in human citrated plasma.
- Brand Name: STA Liatest Free Protein S
- Model/Catalog Number (REF): 00516
- Lot Numbers: 271 971, 272 859, 273 018, 273 426
- Recall Number: Z-1491-2026
- Quantity: 369 units
- Distribution: Worldwide, including US distribution in AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, and WA.
What You Should Do
The firm initiated the recall via email notification on February 4, 2026. Laboratories and healthcare facilities using these kits should immediately check their inventory for the affected lot numbers listed above. For further information, consumers can contact Diagnostica Stago, Inc. at their Parsippany, NJ headquarters located at 5 Century Dr, 07054-4607.
Why This Matters
The underestimation of free protein S levels in normal patient plasmas could lead to incorrect clinical assessments. Accurate protein S measurement is critical for diagnosing potential coagulation disorders, and out-of-range results may lead to unnecessary follow-up or misdiagnosis.
Source
Information provided by the FDA.
Source: FDA Official Notice