FDA recall Z-0712-2024

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-11-21

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2024