Safety recall
Medical
FDA
Is the EnLite Neonatal TREC Kit;an in vitro diagnostic device… safe?
PerkinElmer Health Sciences, Inc. · Recalled Dec 05, 2016
No — the EnLite Neonatal TREC Kit;an in vitro diagnostic device… was recalled on Dec 05, 2016 due to a safety issue. Unique Device Identifier (UDI) is missing from outer kit box label. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Unique Device Identifier (UDI) is missing from outer kit box label.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
EnLite Neonatal TREC Kit;an in vitro diagnostic device…: common questions
Is the EnLite Neonatal TREC Kit;an in vitro diagnostic device… safe?
No. The EnLite Neonatal TREC Kit;an in vitro diagnostic device… was recalled on Dec 05, 2016 due to a safety issue. Unique Device Identifier (UDI) is missing from outer kit box label.
Has the EnLite Neonatal TREC Kit;an in vitro diagnostic device… been recalled?
Yes. The EnLite Neonatal TREC Kit;an in vitro diagnostic device… was recalled on Dec 05, 2016. The recall was issued by FDA (recall ID Z-0897-2017).
Why was the EnLite Neonatal TREC Kit;an in vitro diagnostic device… recalled?
Unique Device Identifier (UDI) is missing from outer kit box label.
What should I do if I have the EnLite Neonatal TREC Kit;an in vitro diagnostic device…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the EnLite Neonatal TREC Kit;an in vitro diagnostic device…?
The official FDA recall record is available
here. Always verify recall details with the official source.
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