Z-2344-2018Class II

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

Name: Z-2344-2018 VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Creator: Ortho-Clinical Diagnostics
Published: 2018-05-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-05-09 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic on 2018-05-09. FDA classified it as Class II and gives the reason as "There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2344-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Posted: 2018-07-03
Terminated: 2020-08-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Product code: DIP Enzyme Immunoassay, Diphenylhydantoin
Reason for recall: There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
FDA root cause: Under Investigation by firm
Action: Urgent Product Correction Notification letters were distributed on 5/9/18. The letters instruct customers to do the following: " Immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. " Complete the Confirmation of Receipt form no later than May 23, 2018. Ortho will replace your remaining inventory of the affected lots or credit your account. " Post this notification by each VITROS System in your facility or with the user documentation. " Forward this notification if the product was distributed outside of your facility. If the customer is a distributor, they were also instructed to: " Send the letter to all customers who were shipped an affected lot of VITROS PHYT Slides.
Quantity in commerce: 5712
Distribution: Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
Product codes and lots: Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2344-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2344-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-03

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)