Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0712-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

QMS Tacrolimus Calibrators, Product code 10015573

Product Classification:

Class II

Date Initiated: November 21, 2023

Date Posted: January 17, 2024

Recall Number: Z-0712-2024

Event ID: 93621

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 10 sales units US; 1 sales unit OUS

Code Information:

No UDI Lot 74859619, Expiry 11-May-2024

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated