VITROS Chemistry Products GLU Slides-Product Code:1707801…

Date

Aug. 14, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

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

Reason

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Distribution pattern

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

Quantity

1099 (5 pack x 60)=329700 slides

Codes and lots

Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Recall started

June 17, 2019

Device type

Glucose Oxidase, Glucose

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-2202-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2202-2019. The agency record governs; check it and the company before acting.