Z-1934-2019Class II

VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036)

Name: Z-1934-2019 VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036)
Creator: Ortho-Clinical Diagnostics
Published: 2019-04-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-04-08 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral... on 2019-04-08. FDA classified it as Class II and gives the reason as "Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems". 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-1934-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Posted: 2019-07-03
Terminated: 2020-11-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Root cause tag: design
FDA root cause: Device Design
Action: On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fresh cartridge of VITROS CK Slides. - If multiple cartridges are loaded on the VITROS 250/350 System, daily QC testing must be performed for each cartridge prior to use. - Consider loading one cartridge of VITROS CK Slides on board your system at a time. - Complete and return the request form via fax to 1-888-557-3759. Foreign affiliates were informed by email on 08 April 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.
Quantity in commerce: 57 units
Distribution: US Nationwide Distribution
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1934-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1933-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03
Z-1934-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03
Z-1935-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03
Z-1936-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03

Product code JJE

K922072Class IKodak Ektachem 250 AnalyerEastman Kodak Company / cleared 1992-07-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)