|
Class 3 Device Recall VITROS Immunodiagnostic Products AntiHBc IgM Controls |
|
Date Initiated by Firm |
October 15, 2021 |
Create Date |
November 17, 2021 |
Recall Status1 |
Terminated 3 on December 18, 2023 |
Recall Number |
Z-0247-2022 |
Recall Event ID |
88875 |
510(K)Number |
K032993
|
Product Classification |
Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
|
Product |
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427
For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems |
Code Information |
Lot 1690
UDI 10758750001200 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr Rochester NY 14626-5101
|
For Additional Information Contact |
Mr. Joe Falvo 585-453-3000
|
Manufacturer Reason for Recall |
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On October 15, 2021, the firm issued "Important Product Correction Notification" letters to affected customers. Customers were informed that up to 8 booklets in the affected lot contained the range of means information for VITROS Immunodiagnostic Products Anti-HBc Controls instead of the control values for VITROS Anti-HBc IgM.
Customers were provided with a copy of the correct Controls Values booklet.
Customers were asked to do the following:
- Complete and return the included Confirmation of Receipt - Response Required customer response form by email to: ra-ocdus-confirmad@orthoclinicaldiagnostics.com or fax to: 1-888-557-3759 or 1-585-453-4110
- Retain the included Controls Values booklet to use in place of any recalled booklets
- Forward the notification if the product was distributed outside your facility
If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311. |
Quantity in Commerce |
191 units |
Distribution |
US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia. |
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 = JJX and Original Applicant = Ortho-Clinical Diagnostics, Inc.
|
|
|
|