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.
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 2/5 (Moderate).
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…
- Affected units
- 5,275
Distribution
Related recalls
Same manufacturer · PerkinElmer Life and Analytical Sciences, Wallac, OY
See all →- ModeratePerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy
FDA (Devices) · 2019-05-08
- ModeratePerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results
FDA (Devices) · 2019-05-08
- ModeratePerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2019-05-08
- LowAutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information
FDA (Devices) · 2018-09-12
- SeverePerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
FDA (Devices) · 2018-05-09
Similar recalls
- SevereMain Street Compounding Pharmacy Recalls Calcium Gluconate Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Acetylcystein 10% Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Dexamethasone LA Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Sodium Hyaluronate Vials
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Dexamethasone LA Due to Skin Abscesses
FDA (Drugs) · 2013-12-11