FDA-Device2024-01-17Class II
QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc.
Hazard
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.
Sold states
Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Affected count
10 sales units US; 1 sales unit OUS
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
QMS Tacrolimus Calibrators, Product code 10015573
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2024Don't want to check this manually?
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