Date Initiated by Firm |
July 10, 2017 |
Create Date |
March 01, 2018 |
Recall Status1 |
Terminated 3 on August 06, 2020 |
Recall Number |
Z-0807-2018 |
Recall Event ID |
78724 |
510(K)Number |
K042006
|
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
Product |
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. |
Code Information |
Lot K4852, Expiration 22 Feb 2018 |
Recalling Firm/ Manufacturer |
Ortho Clinical Diagnostics Inc 1001 US Highway 202 Raritan NJ 08869-1424
|
For Additional Information Contact |
Joe Falvo 585-453-3452
|
Manufacturer Reason for Recall |
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
|
FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452. |
Quantity in Commerce |
10,021 units |
Distribution |
Worldwide |
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.
|
510(K) Database |
510(K)s with Product Code = JJY and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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