Z-1541-2018 Class II Terminated
FDA device recall Z-1541-2018 was initiated by PerkinElmer Life and Analytical Sciences, Wallac, OY on November 17, 2017 and is designated Class II. Reason for recall: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. The recall status is terminated (terminated August 12, 2021). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- November 17, 2017
- Termination Date
- August 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
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.
Reason for Recall
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Distribution Pattern
Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Code Information
All software versions from 1.0 to 1.8 (current software version)