VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistr

FDA device recall Z-0077-2015 · posted 2014-10-16 · Terminated

Recall details

Recalling firm: Ortho-Clinical Diagnostics
Reason for recall: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).
Action taken: On 9/08/14, URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-232, dated 9/8/14) and Confirmation of Receipt Form were sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government only) to inform them of the issue and advise them of the required actions. Foreign affiliates were informed of the issue via e-mail on 9/8/14 and instructed to notify their consignees of the issue and the required actions.
Root cause: Software design
Status: Terminated
Product code: JJE
Quantity affected: USA: 97; Foreign: 232
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Sin
Date initiated: 2014-09-08
Date posted: 2014-10-16
Date terminated: 2018-05-21
Location: Rochester, NY

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144)	Ortho-Clinical Diagnostics, Inc.	2006-11-13
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924)	Ortho-Clinical Diagnostics	2003-08-07