Z-1107-2017Class II

Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and...

Name: Z-1107-2017 Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and...
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2017-01-05
License: https://open.fda.gov/license/

Wallac Oy / initiated 2017-01-05 / Terminated

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body... on 2017-01-05. FDA classified it as Class II and gives the reason as "The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1107-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-05
Posted: 2017-01-27
Terminated: 2017-08-24
Recalling firm: Wallac Oy
Product: Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
FDA root cause: Component change control
Action: The recall was initiated on January 5, 2017 via email sent through the PerkinElmer Technical Support group located in Akron Ohio. Actions to be taken by user: 1. As instructed in the analyte specific kit inserts, the use of Kit Controls is required to assure the day-to-day validity of results. Patient results should only be reported if control results for the assay meet the laboratorys established criteria for acceptability. 2. If a movement error occurs customers will be directed to contact their local PerkinElmer field service representative. The movement error may indicate deterioration of the axle and therefore the use of the instrument should be avoided until field service personnel have inspected the status of the ball bushing axles or replaced affected ball bushing axles. Actions to be taken by the PerkinElmer: As a corrective action, PerkinElmer will replace the affected ball bushing axles in all the GSP instruments identified in this FSCA/Recall. The replacement may take place either as part of the initial installation activity before the instrument is used, scheduled periodic maintenance, or during a dedicated service visit. This field correction is considered as mandatory by the manufacturer. Customers will be contacted by PerkinElmer to arrange the field service visit.
Quantity in commerce: 24 instruments and 3 spare disk remover modules
Distribution: MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Product codes and lots: Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1107-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-27
Z-1108-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-27

Product code KHO

K090846Class IIGsp Instrument and Gsp Neonatal Htsh KitPerkinelmer, Inc. / cleared 2009-09-03

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)