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
FDA Recall Z-1692-2018 · Posted None
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Recalling FirmPerkinElmer Life and Analytical Sciences, Wallac, OY
Recall StatusTerminated
Product CodeNQL
Date Initiated2017-11-02
Date Terminated2019-09-17
Product Quantity5275
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.
Firm 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
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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