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U.S. Department of Health and Human Services

Class 2 Device Recall NeoBase Succinylacetone Assay Solution

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  Class 2 Device Recall NeoBase Succinylacetone Assay Solution see related information
Date Initiated by Firm November 02, 2017
Create Date May 04, 2018
Recall Status1 Terminated 3 on September 17, 2019
Recall Number Z-1692-2018
Recall Event ID 79303
510(K)Number K083130  
Product Classification System, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry - Product Code NQL
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
Code Information Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006
Recalling Firm/
Manufacturer		 PerkinElmer Life and Analytical Sciences, Wallac, OY
Mustionkatu 6
P.O. Box 10
Turku Finland
For Additional Information Contact Joe Sparks
781-663-5714
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQL and Original Applicant = PERKINELMER, INC.
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