Z-0007-2015Class II

VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic...

Name: Z-0007-2015 VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic...
Creator: Ortho-Clinical Diagnostics
Published: 2014-08-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-08-20 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides... on 2014-08-20. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0007-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-20
Posted: 2014-10-02
Terminated: 2017-04-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. 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: Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On 8/20/14, an URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-222, dated 8/20/14) was sent via FedEx overnight courier and/or ORTHO PLUS e-Communications 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) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. One foreign affiliate was notified on 8/20/14. One distributor was notified on 8/20/14. The customers were advised to: - Immediately discontinue using and discard VITROS Chemistry Products PHYT slide Lot 2613-0150-4913. Review VITROS PHYT results obtained using Lot 2613-0150-4913 and discuss any concerns they may have regarding previously reported results with their Laboratory Medical Director or with the requesting physician. Complete the attached Confirmation of Receipt form no later than 8/28/14. Forward the information in this notification if they have distributed this product outside of their facility facility.
Quantity in commerce: Domestic: 339 sales units; Foreign: 10 sales units
Distribution: Distributed USA (nationwide) and in Singapore.
Product codes and lots: Lot Number 2613-0150-4913, exp. 15-Nov-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0007-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02

Product code DIP

K941142Class IIKodak Ektachem Clinical Chemistry Slide PhenytoinEastman Kodak Company / cleared 1994-06-13

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)