Recall Z-0712-2024— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-0712-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-21

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-11-21. It names one FDA 510(k) clearance: K123343. 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..

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-21
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSMicrogenics Corp.·cleared 2013-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

QMS Tacrolimus Calibrators, Product code 10015573

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.