Date Initiated by Firm |
May 06, 2015 |
Date Posted |
June 04, 2015 |
Recall Status1 |
Terminated 3 on September 13, 2017 |
Recall Number |
Z-1707-2015 |
Recall Event ID |
71176 |
510(K)Number |
K964310
|
Product Classification |
Radioimmunoassay, total triiodothyronine - Product Code CDP
|
Product |
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating. |
Code Information |
Lot 3082, expiry date 7/27/2015 |
Recalling Firm/ Manufacturer |
ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom
|
For Additional Information Contact |
Ms. Jennifer Paine 908-218-8776
|
Manufacturer Reason for Recall |
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time. |
Quantity in Commerce |
Domestic: 898 units |
Distribution |
Nationwide Distribution. |
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 = CDP and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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