Z-0897-2017Class III

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of...

Name: Z-0897-2017 EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of...
Creator: PerkinElmer Health Sciences, Inc.
Published: 2016-12-05
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2016-12-05 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer Health Sciences, Inc. began a recall of 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... on 2016-12-05. FDA classified it as Class III and gives the reason as "Unique Device Identifier (UDI) is missing from outer kit box label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0897-2017
Classification: Class III
Status: Terminated
Initiated: 2016-12-05
Posted: 2016-12-22
Terminated: 2017-02-06
Recalling firm: Revvity Health Sciences, Inc.
Product: 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
Product code: PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Reason for recall: Unique Device Identifier (UDI) is missing from outer kit box label.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Customers were notified of the recall via email on December 5, 2016. Technical Support will ensure the customers receive the Recall Letter and understand the recommended actions. Customers were asked to retain this Medical Device Correction in your laboratory documentation until the affected lot inventory is either depleted or reaches expiration and to complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to [email protected] as soon as possible, but not later than December 29, 2016.
Quantity in commerce: 73 kits
Distribution: MA, AK
Product codes and lots: Lot Number: 1065060401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0897-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0897-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code PJI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)