Z-0166-2016Class II

Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and...

Name: Z-0166-2016 Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and...
Creator: Perkin Elmer Life Sciences Inc
Published: 2015-08-24
License: https://open.fda.gov/license/

Wallac Oy / initiated 2015-08-24 / Terminated / root cause: software

FDA source

Perkin Elmer Life Sciences Inc began a recall of Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn... on 2015-08-24. FDA classified it as Class II and gives the reason as "It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the...". 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-0166-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-10-26
Terminated: 2021-01-21
Recalling firm: Wallac Oy
Product: Perkin Elmer Specimen Gate, Screening Center. 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: It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: Ensure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final corrective action is deployed to your site. The final corrective action will involve an installation update to the software. For further information, please contact your local PerkinElmer representative or [email protected]
Quantity in commerce: 6 units
Distribution: US distribution to FL, GA, and NV; and Canada
Product codes and lots: Software Version 1.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0166-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0166-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-26

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)