Recall Z-1541-2018— PerkinElmer Life and Analytical Sciences, Wallac, OY
Class II · Terminated
Class II FDA medical device recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, initiated 2017-11-17, terminated 2021-08-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results..
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2021-08-12
- Firm location
- Turku, N/A, Finland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.