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)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
This recall has been terminated (originally issued November 2, 2017).
- Recall Initiated
- November 2, 2017
- Terminated
- September 17, 2019
- Recall Number
- Z-1692-2018
- Quantity
- 5275
- Firm Location
- Turku Finland
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Distribution
Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
Lot / Code Info
Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006
Root Cause
Process control
Action Taken
Actions to be taken: - Inspect your inventory of the NeoBase Succinylacetone Assay Solution vials for the affected lots. - If you notice leakage or deformed stopper seals, destroy the affected vials according to local instructions and regulations. - Complete the Response Form with the quantity and identity of affected Succinylacetone Assay Solution vials in your inventory. - Return the Response Form to PerkinElmer. - PerkinElmer will replace the quantity of leaking Succinylacetone Assay Solution vials found and destroyed from your inventory