Z-1541-2018Class II

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current...

Name: Z-1541-2018 Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current...
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2017-11-17
License: https://open.fda.gov/license/

Wallac Oy / initiated 2017-11-17 / Terminated / root cause: software

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of Specimen 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... on 2017-11-17. FDA classified it as Class II and gives the reason as "Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1541-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-04-27
Terminated: 2021-08-12
Recalling firm: Wallac Oy
Product: Specimen 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Root cause tag: software
FDA root cause: Software design
Action: PerkinElmer sent an Urgent Medical Device Correction letter dated November 14,2017. Instructions: 1. Implement additional control measures concerning demographic information, by taking one of the following actions a. Fully enter demographics before loading specimens on instruments (i.e. specimens can be punched, but the assay plates cannot be loaded to the measurement instruments). b. If the above mentioned is not possible or if previously entered demographic information changes after loading the assay plates on the measurement instruments, recalculate all your results in Specimen Gate laboratory Result Viewer prior to assay acceptance. 2. Follow unreported specimens with available tools to avoid any delay in reporting screening results. For further questions, please call (317) 418-1735
Quantity in commerce: 8
Distribution: Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Product codes and lots: All software versions from 1.0 to 1.8 (current software version)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1541-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1541-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-27

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)