Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Specialty Diluent

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VITROS Chemistry Products Specialty Diluentsee related information
Date Initiated by FirmMarch 26, 2014
Date PostedApril 28, 2014
Recall Status1 Terminated 3 on March 27, 2017
Recall NumberZ-1519-2014
Recall Event ID 67883
510(K)NumberK962235 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Code Information Lot F3168 (exp. 30 Sep 2014)
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
FDA Determined
Cause 2		Other
ActionOn 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.
Quantity in Commerce1656 distributed (1200 went to warehouse in France)
DistributionNationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
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 = JJE
-
-