Z-1692-2018Class II

NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers...

Name: Z-1692-2018 NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers...
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2017-11-02
License: https://open.fda.gov/license/

Wallac Oy / initiated 2017-11-02 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184... on 2017-11-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Posted: 2018-05-04
Terminated: 2019-09-17
Recalling firm: Wallac Oy
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
Product code: NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code NQL

K083130Class IINeobase Non-Derivatized Msms Kit, Model 3040Perkinelmer, Inc. / cleared 2009-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)