PerkinElmer recalls DELFIA hCG Kit (Product Code A007-101) 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 DELFIA hCG Kits that may show hCG levels up to 20% lower than actual in low concentration ranges. This could lead to inaccurate pregnancy tests or fertility assessments.
The kit may measure hCG concentrations 15-20% lower than actual at low levels. This could cause false negatives in pregnancy tests or inaccurate fertility assessments, but does not cause physical harm.
Users of the DELFIA hCG Kit for pregnancy testing or fertility assessments are affected. Those using the kit for medical purposes may need to retest if results seem inconsistent.
Check for Product Code A007-101 with Lot Numbers 664891, 666471, or 666604. The UDI code starts with (01)06438147009176(17)190430(10) followed by one of the lot numbers.
Look for Lot Numbers 664891, 666471, or 666604 on the kit packaging.
The DELFIA hCG Kit may show hCG levels up to 20% lower than actual at low concentrations, potentially causing false negatives in pregnancy tests.
Check for Product Code A007-101 with Lot Numbers 664891, 666471, or 666604 on the packaging.
No, but if you get inconsistent results, retest with a new kit or consult your healthcare provider.
We’ve drafted a message you can send PerkinElmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1237-2019 — PerkinElmer PerkinElmer Hello, I own a PerkinElmer that is covered by recall Z-1237-2019 from PerkinElmer. 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.
