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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Na Slides

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 Class 2 Device Recall VITROS Chemistry Products Na Slidessee related information
Date Initiated by FirmJanuary 22, 2019
Create DateMarch 09, 2019
Recall Status1 Terminated 3 on June 10, 2022
Recall NumberZ-0992-2019
Recall Event ID 82113
510(K)NumberK081411 
Product Classification Electrode, ion specific, sodium - Product Code JGS
ProductVITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information Lot 4221-0998-3223
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		Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letters dated 1/22/19 to is customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If you have an alternate lot of VITROS Na+ Slides, discontinue using and discard all remaining inventory of Lot 4221-0998-3223. " If you do NOT have an alternate lot, consult with your medical or laboratory director to determine if it is acceptable to continue using the affected lot until your replacement order arrives. " Until you receive your replacement order: o Performing Osmolality calculations on your VITROS System is not recommended. o If you continue using the affected lot, it is strongly recommended to take additional action to detect imprecision, such as performing duplicate testing for each sample. Repeat testing if there is a discrepancy between the results obtained in duplicate testing (i.e., +/- 1.4 mmol/L). o Discard all remaining inventory when your replacement order arrives. An adequate supply of replacement product is available and Ortho will expedite all replacement orders. " Please complete the enclosed Confirmation of Receipt form by e-Mail to RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM or Fax to: 1.888.557.3759 or 1.585.453.4110. Ortho will credit your account or send a replacement order for the discarded slides. " Forward the information in this notification if you have distributed this product outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce1448
DistributionUS Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.
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 = JGS
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