QMS Tacrolimus Calibrators…

Date

Jan. 17, 2024

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

Ongoing

Filed by

Ortho-Clinical Diagnostics, Inc.

Product

QMS Tacrolimus Calibrators, Product code 10015573

Reason

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

Distribution pattern

Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.

Quantity

10 sales units US; 1 sales unit OUS

Codes and lots

No UDI Lot 74859619, Expiry 11-May-2024

Recall started

Nov. 21, 2023

Device type

Calibrator, Secondary

Root cause (FDA)

Storage

What the company told customers

On 21 November 2023, all consignees who were shipped the VITROS QMS Tacrolimus Calibrators Lot 74859619 expiry date: 11-May-2024 from QuidelOrtho distribution center were notified of the issue and instructed to: -Discontinue using, render unusable, and discard your inventory of QMS Tacrolimus Calibrators, Lot 74859619, which was shipped to the laboratory from QuidelOrtho. -Post the notification by the laboratory s inventory storage area until a replacement lot of QMS Tacrolimus Calibrator has been received. -Forward the notification if the affected product was distributed outside their facility. If you have questions about this recall, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.

Recall number

Z-0712-2024

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

Source: FDA · Medical device enforcement report, recall number Z-0712-2024. The agency record governs; check it and the company before acting.