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.
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.
The test kits may give results outside the expected range for normal patient plasmas, leading to underestimation of free protein S levels. This defect only impacts normal-range values and does not cause immediate harm.
Patients using the STA Liatest Free Protein S test kits for blood tests may be affected. Those with normal protein S levels are most at risk of inaccurate results.
Check for model number 00516 on the kit packaging. Affected kits have lot numbers 271971, 272859, 273018, or 273426.
Look for model number 00516 and lot numbers 271971, 272859, 273018, or 273426 on the kit packaging.
The test kits may produce inaccurate results for free protein S levels in normal patient plasmas, leading to underestimation of the protein level.
No, but you should check if your kit is affected before using it. The recall does not require immediate discontinuation.
Check for model number 00516 and lot numbers 271971, 272859, 273018, or 273426 on the packaging.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1491-2026 — Stago Stago Hello, I own a Stago that is covered by recall Z-1491-2026 from Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
