Z-1072-2016Class II

VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD

Name: Z-1072-2016 VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD
Creator: Ortho-Clinical Diagnostics
Published: 2015-12-21
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-12-21 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The... on 2015-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1072-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-03-08
Terminated: 2018-05-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: US = 885; Foreign: 3221
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, Singapore, Spain, and Venezuela
Product codes and lots: Software Version 9.4 and below; Serial Numbers J27000001 - 27004539

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1072-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1072-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1073-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1074-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1075-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code JJE

K922072Class IKodak Ektachem 250 AnalyerEastman Kodak Company / cleared 1992-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)