Z-0273-2018Class II

VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc...

Name: Z-0273-2018 VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc...
Creator: Ortho-Clinical Diagnostics
Published: 2017-06-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-06-12 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry... on 2017-06-12. FDA classified it as Class II and gives the reason as "The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0273-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2017-12-22
Terminated: 2020-08-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) 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: DIP Enzyme Immunoassay, Diphenylhydantoin
Reason for recall: The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Root cause tag: design
FDA root cause: Device Design
Action: Ortho-Clinical Diagnostic sent an Urgent Product Correction Letter dated June 12, 2017, sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who have a VITROS analyzer that can process PHYT Slides to inform them that negatively biased results may occur when processing citrate plasma samples using VITROS Chemistry Products PHYT Slides. Customers were instructed to immediately discontinue using citrate plasma samples to process VITROS PHYT Slides. They were also informed that it is still acceptable to use serum and heparin plasma samples to process VITROS PHYT Slides. Foreign affiliates were informed by e-mail on June 12, 2017 of the issue and instructed to notify their consignees of the issue and the appropriate actions to take. For further questions, please call (908) 218-8776.
Quantity in commerce: US; 4680; Foreign: 1286
Distribution: Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.
Product codes and lots: Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0273-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-22

Product code DIP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)