Z-1519-2014Class II

VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc...

Name: Z-1519-2014 VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc...
Creator: Ortho-Clinical Diagnostics
Published: 2014-03-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-03-26 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY on 2014-03-26. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS...". 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-1519-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-26
Posted: 2014-04-28
Terminated: 2017-03-27
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.
Quantity in commerce: 1656 distributed (1200 went to warehouse in France)
Distribution: Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Product codes and lots: Lot F3168 (exp. 30 Sep 2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1519-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-28
Z-1520-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-28

Product code JJE

K962235Class IVitros Specialty DiluentJohnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-06-26

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)