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Class 2 Device Recall NeoBase Succinylacetone Assay Solution |
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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
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Product Classification |
System, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry - Product Code NQL
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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
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For Additional Information Contact |
Joe Sparks 781-663-5714
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = NQL and Original Applicant = PERKINELMER, INC.
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