Recall Register

PerkinElmer Life and Analytical Sciences, Wallac, OY: FDA recalls

FDA enforcement reports name PerkinElmer Life and Analytical Sciences, Wallac, OY as the recalling firm in 6 events. The events have 9 product records. The recalls started from 2017 to 2019. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of PerkinElmer Life and Analytical Sciences, Wallac, OY
InitiatedProduct (first record)TypeClassRecordsStatus
10 Jan 2019DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.DeviceClass II3Ongoing
17 Nov 2017Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.DeviceClass II1Terminated
2 Nov 2017NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680…DeviceClass II1Terminated
25 Sep 2017AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212DeviceClass III1Terminated
7 Mar 2017Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.DeviceClass II1Terminated
5 Jan 2017Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

PerkinElmer Life and Analytical Sciences, Wallac, OY: events for each product type
TypeEvents
Device6
PerkinElmer Life and Analytical Sciences, Wallac, OY: events in each class
ClassEvents
Class II5
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of PerkinElmer Life and Analytical Sciences, Wallac, OY, by the year that the recall started. The largest year is 2017, with 5 events.

Official channels

Cite this page

Recall Register. PerkinElmer Life and Analytical Sciences, Wallac, OY: FDA recalls. https://recallregister.com/firm/perkinelmer-life-and-analytical-sciences-wallac-oy/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of PerkinElmer Life and Analytical Sciences, Wallac, OY have?
Class II: 5 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of PerkinElmer Life and Analytical Sciences, Wallac, OY?
FDA event 82064, which the firm started on 10 Jan 2019. The first product in the record is: DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
How many FDA recalls of PerkinElmer Life and Analytical Sciences, Wallac, OY have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.