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Terminated

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

FDA Recall Z-0897-2017 · Posted 2016-12-22

Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodePJI
Date Initiated2016-12-05
Date Terminated2017-02-06
Product Quantity73 kits

Reason for Recall

Unique Device Identifier (UDI) is missing from outer kit box label.

Firm 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.

Root Cause

Employee error

Distribution Pattern

MA, AK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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