Data Foundry

Medical device recalls 2018

NeoBase Succinylacetone Assay Solution — Class II medical device recall Z-1692-2018

Terminated recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2018-05-16, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instruct

Recall numberZ-1692-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland
Recall initiated2017-11-02
Classified2018-05-04
Reported by FDA2018-05-16
Terminated2019-09-17
DistributedAL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX
Quantity5,275
Reason classespackaging
UPC / GTIN / UDI-DI06438147295708
Lot numbers653414, 653657, 654184, 654923, 654924, 655300, 655680, 656025, 656170, 656320, 657055, 657513, 657768, 658006

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)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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1692-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.