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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 Packsee related information
Date Initiated by FirmAugust 28, 2018
Create DateNovember 06, 2018
Recall Status1 Terminated 3 on August 11, 2020
Recall NumberZ-0392-2019
Recall Event ID 81066
510(K)NumberK013899 K984321 
Product Classification Radioassay, vitamin b12 - Product Code CDD
ProductVITROS 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
FEI Number 1000136573
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactJoe 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
ActionThe 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 Commerce6630
DistributionWorldwide 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 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 = CDD
510(K)s with Product Code = CDD
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