PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk
PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (data mismatch) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling Specimen Gate Screening Center software, versions 1.4 and 1.6 (Product Code: 5002-0500). The software is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
The recall is being conducted because of a potential for demographic information and test results to be mismatched. This defect could lead to incorrect data association within the laboratory system.
Thirteen devices are affected by this recall. The software was distributed worldwide, including in the United States (Massachusetts, Georgia, Florida, Nevada) and internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and the United Kingdom. Users should contact PerkinElmer Health Sciences, Inc. for further instructions regarding the recall.
The recalled product
- Product
- PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Hazard
- Affected units
- 13
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 (3)
- Product Code: 5002-0500
- Software Versions
- 1.4 and 1.6
Distribution
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