FDAClass IIJanuary 17, 2024

QMS Tacrolimus Calibrators recall

QMS Tacrolimus Calibrators, Product code 10015573

Why was QMS Tacrolimus Calibrators recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

No UDI Lot 74859619, Expiry 11-May-2024

Product
QMS Tacrolimus Calibrators, Product code 10015573
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
10 sales units US; 1 sales unit OUS
Distribution
Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Recall date
January 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls