| Class 3 Device Recall VITROS Chemistry Products | |
Date Initiated by Firm | May 09, 2013 |
Date Posted | June 27, 2013 |
Recall Status1 |
Terminated 3 on June 12, 2015 |
Recall Number | Z-1614-2013 |
Recall Event ID |
65247 |
510(K)Number | K083680 |
Product Classification |
Electrode, ion specific, potassium - Product Code CEM
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Product | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596,
Product Usage:
For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. |
Code Information |
GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014). The term GEN and Coating refer to specific segments of the reagent lot number. |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Ms. Jennifer Paine 908-218-8776 |
Manufacturer Reason for Recall | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process. |
FDA Determined Cause 2 | Employee error |
Action | Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 9, 2013 via FedEx or US Priority Mail to all US customers. Foreign Affiliates were notified by e-mail on May 9, 2013 informing them of the issue. Distributors were instructed to notify their customers of the recall. Customers were instructed to discontinue use, discard the affected product, comp[lete and return the attached Confirmation of Recipt Form, and post this notification by each VITROS System. For questions call Customer Service Center at 1-800-828-6316. |
Quantity in Commerce | Domestic: 236,364; Foreign: 8,339 |
Distribution | Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela. |
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 = CEM
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