Perkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation
Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Perkin Elmer Life Sciences Inc is recalling 6 units of Specimen Gate, Screening Center software, version 1.6. This software is used by qualified laboratory personnel to manage data for neonatal screening test results and demographics in newborn screening programs.
The recall is due to a defect where an abnormal analytical test result value from an affected newborn could be reported with a default result interpretation of normal. While the analytical test result value itself would be correct, the interpretation of that value would be incorrect.
The affected software was distributed in the United States to Florida, Georgia, and Nevada, as well as in Canada. The source text does not specify specific actions for consumers or laboratories beyond the recall notice.
The recalled product
- Product
- Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
- Manufacturer
- Perkin Elmer Life Sciences Inc
- Affected units
- 6
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)
- Software Version 1.6
Distribution
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