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

FDA device recall Z-0897-2017 · posted 2016-12-22 · Terminated

Recall details

Recalling firm

PerkinElmer Health Sciences, Inc.

Reason for recall

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

Action taken

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 TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 29, 2016.

Root cause

Employee error

Status

Terminated

Product code

PJI

Quantity affected

73 kits

Distribution

MA, AK

Date initiated

2016-12-05

Date posted

2016-12-22

Date terminated

2017-02-06