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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack see related information
Date Initiated by Firm August 28, 2018
Create Date November 06, 2018
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-0392-2019
Recall Event ID 81066
510(K)Number K984321  K013899  
Product Classification Radioassay, vitamin b12 - Product Code CDD
Product VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489

For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
Code Information Lot 2601, 2610, 2620
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 The reagent pack exhibits the potential for an increased frequency of calibration failures.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 8/28/18 to customers. A second "IMPORTANT UPDATE: PRODUCT CORRECTION NOTIFICATION" letter dated 10/22/18 was distributed to customers to inform them of additional affected lots. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: If this lot was successfully calibrated and your quality control results are acceptable; you may continue using your existing inventory of VITROS Vitamin B12 Reagent Pack 1/2 Lot 2601 until your replacement order arrives. We advise that you perform quality control on every reagent pack. " If this lot cannot be successfully calibrated, contact our Ortho Care" Technical Solutions Center. " Complete the Confirmation of Receipt  Response Required form and return by September 12, 2018 (so that we can credit your account or expedite your replacement order) via Fax: to: 1.888.557.3759 or 1.585.453.4110 or e-Mail to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. " Discontinue using Lot 2601 upon receipt of your replacement order. " Post this notification by each system that processes VITROS Vitamin B12 Reagent Pack 1/2. " Forward this notification if the product was distributed outside of your facility The distributors were instructed to do the following: Discontinue distributing and discard all inventory of VITROS Vitamin B12 Reagent Pack 1/2 and Calibrators for Lot 2610 and/or 2620. " Send the customer letter to all customers who were shipped VITROS Vitamin B12 Reagent, Lots 2610 and/or 2620 from your facility. " Complete and return the Confirmation of Receipt form no later than November 5, 2018. " Forward this notification if you have distributed this product outside of your facility. If you have further questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 6630
Distribution Worldwide Distribution: US (nationwide) to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of: Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.
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 = CDD and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
510(K)s with Product Code = CDD and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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