Z-0848-2015Class II

VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry...

Name: Z-0848-2015 VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry...
Creator: Ortho-Clinical Diagnostics
Published: 2014-11-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-11-06 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure... on 2014-11-06. FDA classified it as Class II and gives the reason as "Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides". 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-0848-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Posted: 2014-12-22
Terminated: 2017-02-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code: CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Reason for recall: Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in commerce: USA: 380 units, Foreign: 155 units
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Product codes and lots: Lot 0704-3318-4774 (expiry date 01 Dec 2015)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0848-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-22

Product code CDT

K812029Class IKodak Ektachem Clin. Chem. Slides (Trig)Eastman Kodak Company / cleared 1981-08-03

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)