Alere fertility test kits from June 2021-August 2021 may have been affected by temperature changes during shipping, potentially reducing effectiveness. Check product details to see if your kit is included.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Alere fertility test kits sold between June 1 and September 30, 2021, may have been impacted by temperature changes during shipping. This could reduce the test's effectiveness, but the risk is not serious enough to require immediate action.
Temperature changes during shipping from June 2021 to August 2021 could have reduced the test's effectiveness. The product was shipped in facilities that experienced temperature excursions, meaning it might have been exposed to higher temperatures than recommended.
People who purchased Alere fertility test kits with model numbers 92210 or 92211 between June 1 and September 30, 2021. Pregnant individuals using these tests are most at risk of inaccurate results.
Check for model numbers 92210 (30 tests) or 92211 (50 tests) on the packaging. The product was sold between June 1 and September 30, 2021, with GTINs starting with 10815845020130 or 10815845020093.
Look for model numbers 92210 or 92211 on the packaging to confirm if your kit is affected.
No, the recall does not require discarding the tests. The issue is about potential reduced effectiveness, not safety risks.
Check the model number on the packaging. Kits with model numbers 92210 (30 tests) or 92211 (50 tests) sold between June 1 and September 30, 2021, are affected.
The recall does not mention any remedy or fix. Affected kits may still be used but could have reduced effectiveness.
We’ve drafted a message you can send Alere to request your refund or repair — edit it as you like.
Subject: Recall Z-1606-2022 — Alere Alere Hello, I own a Alere that is covered by recall Z-1606-2022 from Alere. 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.
