CLASS III Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
EnLite Neonatal TREC Kit;an recalled by PerkinElmer Health Sciences
PerkinElmer Health Sciences is recalling EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative, distributed in Alaska, Massachusetts. The recall was initiated on 5 Dec 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0897-2017
- FDA event ID
- 75862
- Recalling firm
- PerkinElmer Health Sciences
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Dec 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Dec 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +17 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unique Device Identifier (UDI) is missing from outer kit box label.
Product as listed by the FDA
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Where it was distributed
MA, AK
Questions about this recall
Why was it recalled?
Unique Device Identifier (UDI) is missing from outer kit box label.
Which lots are affected?
Lot Number: 1065060401
Where was it sold?
MA, AK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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