The Recall Desk
HighFDA (Devices)·Z-1491-2026·Announced 2026-03-11

[pending] Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Numb

Pending LLM rewrite. Source: FDA_DEVICE Z-1491-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

Product
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The 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
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Model/Catalog Number (REF): 00516
  • UDI: (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
  • Lot numbers: (1) 271 971
  • (2) 272 859
  • (3) 273 018
  • (4) 273 426
  • Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516

Distribution

Distributed nationwide across the United States.

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