Abbott recalls ARCHITECT DHEA-S reagent kits that may produce falsely elevated DHEA-S test results when used on infants up to 60 days old. Affected lots have specific expiration dates and unique identifiers.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Abbott is recalling ARCHITECT DHEA-S reagent kits that may give falsely high results when testing infants under 60 days old. This could lead to incorrect health assessments for very young babies.
The reagent may produce falsely elevated DHEA-S test results when used with samples from infants up to 60 days old. This could lead to incorrect health assessments for very young babies.
Parents or caregivers using these reagent kits to test infants under 60 days old for DHEA-S levels are most at risk of getting inaccurate results.
Check for specific lot numbers and expiration dates listed in the recall: Lot No. 01316K000 (exp. 04FEB2018), Lot No. 01217A000 (exp. 13APR2018), and other lots with similar patterns in the product description.
Look for the lot number on the reagent kit, such as 01316K000, 01217A000, or similar codes listed in the recall notice.
The reagent may produce falsely elevated DHEA-S test results when used with samples from infants up to 60 days old, which could lead to incorrect health assessments.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected lot numbers.
Check the lot number on the reagent kit, which should match the specific codes listed in the recall (e.g., 01316K000, 01217A000).
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2018 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1629-2018 from Abbott. 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.
