Z-1761-2017Class II

Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data...

Name: Z-1761-2017 Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data...
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2017-03-07
License: https://open.fda.gov/license/

Wallac Oy / initiated 2017-03-07 / Terminated / root cause: software

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving... on 2017-03-07. FDA classified it as Class II and gives the reason as "Potential for errors in patient results generated by the Specimen Gate Laboratory Software". 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-1761-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-03-13
Terminated: 2021-05-10
Recalling firm: Wallac Oy
Product: Specimen 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Root cause tag: software
FDA root cause: Software design
Action: PerkinElmer Life and Analytical Sciences sent an Urgent Medical Device Correction letter dated March 7, 2017, to all affected consignees. The letter contains the following instructions: Until PerkinElmer's corrective measures are completed, we request our customers to close the Specimen Gate Laboratory Result Viewer between viewing and especially between manually calculating assay results. Closing and reopening the Result Viewer between processing the results from different assays effectively prevents the described issues from occurring. We also request our customers to follow unreported specimens with available tools to avoid any delay in reporting screening results. The available tools will vary depending on their process or the LIMS system that is used for activities associated with management of patient demographics, patient reports and the overall management of data generated from newborn screening testing. The final corrective action will involve an installation update to the software. PerkinElmer will deploy an installation update that will prevent the described issue when assays are calculated during the same Result Viewer session without closing it between the processing of different assays. Once the installation update is available, Software Services will contact you and arrange for the deployment. The installation update will be provided to you free of charge. Customers were instructed to complete the enclosed response form and return it by fax to 1-330-825-8520 (US) =358 2 2678 357 (OUS). For questions regarding this recall call 317-418-1735.
Quantity in commerce: 29
Distribution: Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Product codes and lots: Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1761-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1761-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07

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)