The Recall Desk
ModerateFDA (Devices)·Z-1692-2018·Announced 2018-05-16

PerkinElmer Recalls NeoBase Succinylacetone Assay Solution Due to Leaking Vials

PerkinElmer is recalling NeoBase Succinylacetone Assay Solution because leaking vials may cause minor allergic skin reactions if proper attire is not used.

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 explicitly describes the hazard as a 'transient minor allergic skin reaction' and notes that proper attire prevents the issue, fitting the criteria for moderate severity.

Plain-English summary

PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 5,275 units of NeoBase Succinylacetone Assay Solution, Product Number 3042-0020. The recall affects specific lot numbers distributed in 20 US states, including Alabama, Arizona, California, and Texas.

The recall was initiated because there is a potential for the vials to leak. If proper attire is not used as instructed, handling the leaking succinylacetone reagent vials may result in a transient minor allergic skin reaction.

Healthcare facilities and laboratories should stop using the affected product and contact PerkinElmer for instructions on how to return or dispose of the recalled units.

The recalled product

Product
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10
Affected units
5,275

Distribution