PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks to patient data integrity in medical screening.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling the Specimen Gate Screening Center, Part Number 5002-0500. The recall covers all software versions from 1.0 to 1.8, which is the current version. This software is used by qualified laboratory personnel in newborn screening programs to manage data for neonatal screening test results and demographics.
The recall was initiated because the product may generate potential errors in patient results. These errors include both false negative and false positive results. The agency has classified this as a Class II recall.
The product was distributed worldwide, including in the United States (specifically the state of Georgia) and in Belgium, Canada, Denmark, Italy, and the United Kingdom. A total of 8 units are affected. Consumers and laboratory personnel should contact the recalling firm for further instructions on how to address the software errors.
The recalled product
- 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…
- Category
- Medical Device — Software
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All software versions from 1.0 to 1.8 (current software version)
Distribution
Distributed in 1 state:
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