Summary
The FDA issued a Class II for QMS Tacrolimus Calibrators, Product code 10015573 by Ortho-Clinical Diagnostics, Inc.. Reason: Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expe.
Details
Source
Device Recall
External ID
Z-0712-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
QMS Tacrolimus Calibrators, Product code 10015573
Lot/Code Info: No UDI Lot 74859619, Expiry 11-May-2024
Quantity Affected: 10 sales units US; 1 sales unit OUS
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-21
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0712-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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