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Ortho-Clinical Diagnostics, Inc. Recall 93621

Description: QMS Tacrolimus Calibrators, Product code 10015573

Ortho-Clinical Diagnostics, Inc. Recall 93621 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0712-2024
Event ID93621
Event DescriptionQMS Tacrolimus Calibrators, Product code 10015573
Product TypeDevices
DistributionDomestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Quantity10 sales units US; 1 sales unit OUS
Recall ReasonOrtho-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.
Device Classification20240117
Device Code InfoNo UDI Lot 74859619, Expiry 11-May-2024
Center Classification Date20240111
Recall Initiation Date20231121
Recalling FirmOrtho-Clinical Diagnostics, Inc.
Initial Notification Letter
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