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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 Recall
VITROS 5,1 FS Chemistry System
see related information
Date Posted August 16, 2007
Recall Status1 Open
Recall Number Z-1167-2007
Recall Event ID 38217
Premarket Notification
510(K) Numbers
K031924  K063144 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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, New York 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
DESIGN: Software Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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