PerkinElmer recalls AutoDELFIA hCG Kit (Product Code B007-101) due to potential 15-20% lower hCG analyte concentrations at low measurement ranges. Affected kits have specific lot numbers and UDI codes.
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
PerkinElmer is recalling AutoDELFIA hCG Kits (Product Code B007-101) because they may measure human hCG levels up to 20% lower than expected at low concentrations. This could lead to inaccurate pregnancy tests or fertility assessments.
The kit may produce hCG measurements that are 15-20% lower than expected when testing low concentrations of human gonadotropin. This could cause false negative results in pregnancy tests or fertility assessments.
Users of the AutoDELFIA hCG Kit for pregnancy testing or fertility assessments are affected. Those using the kit for low hCG concentration measurements are most at risk.
Check for Product Code B007-101 with specific lot numbers: 664670, 666553. Also look for UDI codes starting with (01)06438147009336(17)190430(10) followed by the lot number.
Look for lot numbers 664670, 666553 on the kit packaging.
The kit may measure human hCG levels up to 20% lower than expected at low concentrations, potentially causing false negative results.
Check the kit lot numbers and UDI codes to see if it's affected. If it is, contact PerkinElmer for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send PerkinEl:mer to request your refund or repair — edit it as you like.
Subject: Recall Z-1238-2019 — PerkinEl:mer PerkinEl:mer Hello, I own a PerkinEl:mer that is covered by recall Z-1238-2019 from PerkinEl:mer. 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.
