PerkinElmer recalls AutoDELFIA hCG Kit (Product Code B007-112) due to potential 15-20% lower hCG analyte concentrations at low measurement ranges. Affected kits have specific lot numbers.
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
PerkinElmer is recalling AutoDELFIA hCG Kits that may show 15-20% lower hCG concentrations at low measurement levels. This could lead to inaccurate pregnancy tests or fertility assessments. The recall affects specific lot numbers of the kit.
The kit may measure hCG concentrations 15-20% lower than actual levels at the lower end of the measurement range. This could cause false negative results in pregnancy tests or inaccurate fertility assessments. The issue is specific to certain lot numbers and does not cause physical harm.
Users of the AutoDELFIA hCG Kit for pregnancy testing or fertility assessments. Those with specific lot numbers (664303) and pack lot numbers (1066430301, 1066430302) are most at risk.
Check for Product Code B007-112 with Lot Number 664303 and Pack Lot Numbers 1066430301 or 1066430302. The kit is used for quantitative hCG testing in pregnancy and fertility assessments.
Look for Lot Number 664303 and Pack Lot Numbers 1066430301 or 1066430302 on the kit packaging.
The recall is due to potential 15-20% lower hCG analyte concentrations at low measurement ranges, which could lead to inaccurate pregnancy or fertility test results.
Check for Product Code B007-112 with Lot Number 664303 and Pack Lot Numbers 1066430301 or 1066430302 on the kit packaging.
The recall does not require immediate action; check the lot numbers and contact PerkinElmer if you have the specific lot numbers.
We’ve drafted a message you can send PerkinEl:mer to request your refund or repair — edit it as you like.
Subject: Recall Z-1239-2019 — PerkinEl:mer PerkinEl:mer Hello, I own a PerkinEl:mer that is covered by recall Z-1239-2019 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.
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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.
