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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products Signal Reagent

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 Class 3 Device Recall VITROS Immunodiagnostic Products Signal Reagentsee related information
Date Initiated by FirmMay 06, 2015
Date PostedJune 04, 2015
Recall Status1 Terminated 3 on September 13, 2017
Recall NumberZ-1707-2015
Recall Event ID 71176
510(K)NumberK964310 
Product Classification Radioimmunoassay, total triiodothyronine - Product Code CDP
ProductVITROS 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
FEI Number 3007111389
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information ContactMs. 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
ActionOn 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 CommerceDomestic: 898 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CDP
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