PerkinElmer Health Sciences, Inc.

FDA recalling firm · 8 enforcement events · 10 product records · 2014–2017 · MA, SC

PerkinElmer Health Sciences, Inc. has 8 FDA enforcement events on this register (10 product records) between 2014 and 2017: 8 device; the busiest year was 2016 with 4.

0% of its events are Class I; the most common class is Class III (5). 0 events are listed as ongoing; the recalling firm's address is in MA and SC.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
19 Dec 2017	PerkinElmer 226 Sample Collection Device	Device	Class III	1	Terminated
31 May 2017	PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.	Device	Class III	1	Terminated
21 Dec 2016	AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved…	Device	Class III	3	Terminated
5 Dec 2016	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…	Device	Class III	1	Terminated
1 Dec 2016	Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that…	Device	Class II	1	Terminated
16 Nov 2016	DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum	Device	Class III	1	Terminated
1 Jul 2014	Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification…	Device	Class II	1	Terminated
27 Jun 2014	PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.	Device	Class II	1	Terminated

By type and class

Device8

Class III5

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for PerkinElmer Health Sciences, Inc. by year initiated.

Questions and answers

How many FDA recalls has PerkinElmer Health Sciences, Inc. had?

8 enforcement events (10 product records) on this register, 2014–2017: 8 device.

Are any PerkinElmer Health Sciences, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are PerkinElmer Health Sciences, Inc. recalls?

5 Class III, 3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.