Diagnostica Stago recalls Staclot LA test kits that may produce shortened results outside 15 seconds. Affected kits have lot numbers 251918 or 252751.
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 and Staclot LA 20 test kits that may show results outside the normal 15-second timeframe. This could lead to inaccurate lupus anticoagulant testing.
The test kits may produce results that take longer than 15 seconds to recover, which could lead to inaccurate lupus anticoagulant testing. This might cause incorrect health decisions if the results are not properly interpreted.
People using Staclot LA test kits for lupus anticoagulant testing are likely affected. Those who have the specific lot numbers 251918 or 252751 are most at risk.
Check the lot number on the Staclot LA test kit packaging. Affected kits have lot numbers 251918 or 252751.
Look for lot numbers 251918 or 252751 on the test kit packaging.
The recall is happening because some Staclot LA test kits may produce results outside the normal 15-second timeframe, which could lead to inaccurate lupus anticoagulant testing.
Check the lot number on the test kit packaging. If it's 251918 or 252751, you should stop using it and contact Diagnostica Stago for further instructions.
The recall indicates a potential for inaccurate results, but there are no immediate safety risks like injury or fire. The hazard is related to test accuracy, not physical harm.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-0610-2019 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-0610-2019 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.
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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.