VITROS 5,1 FS Chemistry System…

Date

Sept. 9, 2015

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

Reason

Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS 5,1 FS Chemistry System from the ADD instead of retaining the user modified parameters.

Distribution pattern

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

Quantity

Catalog 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147

Codes and lots

Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897.

Recall started

June 30, 2015

Device type

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Root cause (FDA)

Software design

What the company told customers

The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated 6/30/15 and response forms to customers via FedEx overnight courier, e-mail (ORTHO PLUS e-Communications) and/or via US Postal Service overnight letter on 6/30/2015. Foreign affiliates were informed by email on 6/30/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the required actions and complete and return the Confirmation of Receipt-Response Required form, no later than 7/8/15, by fax at 1.888.557.3759 or 1.585.453.4110, or scan PDF and email to: ConfirmationAdmin@its.jnj.com. Customers with any additional questions, can contact Customer Technical Services at 1-800-421-3311 at any time.

Recall number

Z-2544-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2544-2015. The agency record governs; check it and the company before acting.