[Recalled] Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. — It would be possible for an abnormal analytical
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. |
|---|---|
| Brand / manufacturer | Perkin Elmer Life Sciences Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0166-2016 |
| Country of notice | Finland |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 August 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Finland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.