EnLite Neonatal TREC Kit recall
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA…
Why was EnLite Neonatal TREC Kit recalled?
Unique Device Identifier (UDI) is missing from outer kit box label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 1065060401
- Product
- EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA…
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Quantity
- 73 kits
- Distribution
- MA, AK
- Recall date
- December 28, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)