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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 5,1 FS Chemistry System

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  Class 2 Device Recall VITROS 5,1 FS Chemistry System see related information
Date Initiated by Firm May 17, 2007
Date Posted August 16, 2007
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-1167-2007
Recall Event ID 38217
510(K)Number K031924  K063144  
Product Classification in vitro diagnostic - Product Code JJE
Product VITROS¿ 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS¿ Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.
Code Information Software Version 2.2.1, Serial Numbers 34000121 to 34001377.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626-5101
Manufacturer Reason
for Recall		 Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS¿ Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabi
FDA Determined
Cause 2		 Other
Action On 5/17/07, OCD informed its foreign affiliates of the field correction by e-mail, and instructed them to inform their customers who received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents of this issue. On 5/18/07, all US OCD direct customers and end-use customers of consignees that received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents, were informed of the "field correction" by US Postal Service letter, provided with a new Assay Data Disk (ADD #5465), and were instructed to load it and recalibrate these assays, if necessary.
Quantity in Commerce Domestic: 604, International: 598
Distribution Nationwide and Worldwide
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 = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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