Perkinelmer Recalls NEOBASE MSMS Kits Due to Defective Microplate Wells
Perkinelmer is recalling NEOBASE Non-Derivatized MSMS Kits because the microplate wells used in the assays are defective. This may affect the accuracy of newborn metabolic disorder screening.
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 involves a medical device used for newborn screening where defective components could lead to inaccurate diagnostic results. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not explicitly classified as FDA Class I or associated with reported hospitalizations.
Plain-English summary
Perkinelmer is recalling 819 units of the NEOBASE Non-Derivatized MSMS Kit (Product Number 3040-001U). The recall is due to truncated V-bottomed microplate wells used in the assays, which contain defective wells. The affected lot numbers are 617253, 617346, 618494, 618653, 618764, and 619453.
The product was distributed nationwide. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples. The quantitative analysis is intended to aid in screening newborns for metabolic disorders.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries. Users should refer to the official FDA recall notice for specific instructions on how to handle the defective product.
The recalled product
- Product
- NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from
- 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 (6)
- Lot Numbers: 617253
- 617346
- 618494
- 618653
- 618764
- 619453
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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