Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells
Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The defect is a manufacturing issue with the microplate wells, which fits the criteria for a moderate severity recall involving a potential for adverse health consequences that is not likely to cause serious adverse health consequences or death.
Plain-English summary
Perkinelmer is recalling specific lots of the Neonatal Total Galactose Kit, product numbers 3029-0010 and 3029-001B. The recall involves 1,562 kits of product number 3029-0010 and 13 kits of product number 3029-001B. The affected lot numbers are 618201, 619200, and 618263. These kits were distributed nationwide.
The recall was initiated because the truncated V-bottomed microplate wells used in the assays contain defective wells. This kit is intended for the quantitative determination of total galactose concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Healthcare facilities and laboratories that have these specific product numbers and lot numbers should stop using the affected kits and contact Perkinelmer for instructions on how to return or dispose of the product.
The recalled product
- Product
- NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper a
- Manufacturer
- Perkinelmer
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)
- Lot Numbers: 618201
- 619200
- 618263
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Perkinelmer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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