FDA Enforcement Class II Terminated

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

Recall: Z-1692-2018 · Reported May 16, 2018

Enforcement

Recall Number: Z-1692-2018
Event ID: 79303
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: PerkinElmer Life and Analytical Sciences, Wallac, OY
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: E-Mail
Report Date: May 16, 2018
Initiation Date: November 2, 2017
Classification Date: May 4, 2018
Termination Date: September 17, 2019
Address: Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

Description

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.

Code Info

Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006

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.

Quantity

5275