Recall Z-1692-2018 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
PerkinElmer Life and Analytical Sciences, Wallac, OY
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
| Date | Nov 2, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 5275 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 Perkinelmer, Inc., Jul 9, 2009 |