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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products CRBM Slides

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  Class 2 Device Recall VITROS Chemistry Products CRBM Slides see related information
Date Initiated by Firm March 05, 2014
Date Posted April 17, 2014
Recall Status1 Terminated 3 on February 28, 2017
Recall Number Z-1470-2014
Recall Event ID 67788
510(K)Number K980283  
Product Classification Enzyme immunoassay, carbamazepine - Product Code KLT
Product VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information Lot 3920-0080-8403, expiry date 15-JUNE-2014
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remaining inventory of VITROS CRBM Slides, Lot 3920-0800-8403; review previously reported results using this lot; discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician; complete the attached Confirmation of Receipt form no later than March 14, 2014; and forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.
Quantity in Commerce 20 units
Distribution US Distribution to states of: IN, MD, and TN.
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 = KLT and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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