PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors
PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant harm (errors in patient results) are categorized as Severe.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 29 units of Specimen Gate Laboratory software, Product Number 5002-0180. The software is intended for use as a data processing tool for the storage, retrieving, and processing of laboratory data. The recall is due to a potential for errors in patient results generated by the software.
The affected software versions are 1.3 Rev2, 1.7, 1.8, 1.9, and 1.9 Rev2. The products were distributed worldwide, including in the United States (AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA) and internationally to Canada and Brazil.
This recall is classified as Class II by the FDA. Users of the software should contact PerkinElmer Life and Analytical Sciences, Wallac, OY for further instructions on how to address the potential data errors.
The recalled product
- Product
- Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
- Hazard
- Affected units
- 29
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 (5)
- Software Version: 1.3 Rev2
- 1.7
- 1.8
- 1.9
- 1.9 Rev2
Distribution
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