Reported Mar 11, 2026 · Ongoing
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516…
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?
- Brand NameSTA
- Liatest Free Protein S Product NameSTA Liatest Free
- Protein S Model/Catalog Number (REF)00516
- Product DescriptionThe STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method
- ComponentNot Applicable
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 Model/Catalog Number (REF): 00516 2 03607450005165036074500051650360745000516503607450005165UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516 3 Lot numbers: (1) 271 971, (2) 272 859, (3) 273 018, (4) 273 426 4 03607450005165Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516 - Amount recalled
- 369
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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