—#140259

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. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K031924, K063144
Affected lot / code info: 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.

Why it was recalled

Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Ortho Clinical Diagnostics, sent a "FOLLOW UP to URGENT PRODUCT CORRECTION NOTIFICATION" letter dated 9/10/2015 and response forms to customers via FedEx overnight courier, e-mail (ORTHO PLUS e-Communications) and/or via US Postal Service overnight letter on 9/10/2015. Foreign affiliates were informed by email on 9/10/2015 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 9/18/15, 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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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.

Timeline

Recall initiated: 2015-09-10
Posted by FDA: 2015-11-05
Terminated: 2018-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.