—#174082

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

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K182072, K955286
Affected lot / code info: Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Why it was recalled

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

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

Timeline

Recall initiated: 2019-06-17
Terminated: 2020-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.