Z-1088-2014Class II

VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road...

Name: Z-1088-2014 VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road...
Creator: Ortho-Clinical Diagnostics
Published: 2013-10-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-10-17 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator... on 2013-10-17. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1088-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2014-02-25
Terminated: 2018-05-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated October 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Ortho Clinical Diagnostics recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample. Please forward a copy of the notification letter if the products were further distributed. Complete and return the attached Confirmation of Receipt form by October 25, 2013. Customers with questions please call Customer Technical Service at 1-800-421-3311.
Quantity in commerce: 19,368 units total (10,328 for lot 212 and 9,040 for lot 292)
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.
Product codes and lots: Product Code 1662659; Lots: 1) 212 and 2) 292; Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1088-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1087-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25
Z-1088-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code JIX

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)