Recall Z-1541-2018 ยท JQP Calculator/Data Processing Module, For Clinical Use
PerkinElmer Life and Analytical Sciences, Wallac, OY
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.
| Date | Nov 17, 2017 |
| Status | Terminated |
| Reason | Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. |
| 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 labor |
| Quantity | 8 |
| Distribution | Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.