Z-2202-2019Class II

VITROS Chemistry Products GLU Slides-

Name: Z-2202-2019 VITROS Chemistry Products GLU Slides-
Creator: Ortho-Clinical Diagnostics
Published: 2019-06-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-06-17 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in... on 2019-06-17. FDA classified it as Class II and gives the reason as "Potentially Biased Results using VITROS Chemistry Products GLU Slides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2202-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-17
Posted: 2019-08-06
Terminated: 2020-11-09
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Potentially Biased Results using VITROS Chemistry Products GLU Slides
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho issued On 17 June 2019, a customer letter (Ref. CL2019-172) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to customers and distributors. The customers were notified of the issue and instructed: Discontinue using Lot 0048-0964-9287, discard any remaining inventory and switch to an alternate lot. " If you do NOT have an alternate lot, consider the following alternate options: o Use an alternate glucose method until your replacement order arrives. o Consult with your medical director to determine if the bias observed and rate of occurrence when using the affected lot is acceptable for continued use, and if so, continue to use until your replacement arrives. " Ortho will credit and/or replace your remaining inventory of Lot 0048-0964-9287. Please specify full and/or partial sales units remaining and indicate your preference of credit or replacement on your Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than June 21, 2019. " Post this notification by each system that processes VITROS GLU Slides or with your user documentation until you switch to an alternate lot. " Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 1099 (5 pack x 60)=329700 slides
Distribution: US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Product codes and lots: Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2202-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code CGA

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)