Diagnostica Stago recalls Staclot LA 20 test kits with reported shortened results. Affected lots may cause inaccurate lupus anticoagulant testing.
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Diagnostica Stago is recalling Staclot LA 20 test kits that have been reported to show shortened results. This could lead to inaccurate lupus anticoagulant testing, which might affect medical decisions.
The test kits may produce results that recover outside the normal 15-second timeframe. This could lead to inaccurate lupus anticoagulant detection, potentially affecting medical decisions.
People using Staclot LA 20 test kits for lupus anticoagulant testing. Those who have the specific affected lots are most at risk of inaccurate results.
Check the lot numbers: 251504, 251916, 252243, 252364, 252887, 253211. The product is a reagent system for lupus anticoagulant testing in plasma.
Look for the lot numbers 251504, 251916, 252243, 252364, 252887, or 253211 on the test kit packaging.
The Staclot LA 20 test kit is a reagent system designed for the qualitative detection of lupus anticoagulants in plasma.
Affected lots are 251504, 251916, 252243, 252364, 252887, and 253211.
No, the recall does not require stopping use. The issue is with specific lots that may cause inaccurate results.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-0611-2019 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-0611-2019 from Diagnostica 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
