VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage

FDA device recall Z-1074-2016 · posted 2016-03-08 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Action taken

Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.

Root cause

Error in labeling

Status

Terminated

Product code

JJE

Quantity affected

US = 1009; Foreign = 1003

Distribution

Worldwide Distribution - US 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

2015-12-21

Date posted

2016-03-08

Date terminated

2018-05-30

Location

Rochester, NY

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