QMS Tacrolimus Calibrators, Product code 10015573
Reported: January 17, 2024 Initiated: November 21, 2023 #Z-0712-2024
Product Description
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 10 sales units US; 1 sales unit OUS
- Distribution
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
QMS Tacrolimus Calibrators, Product code 10015573. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 10 sales units US; 1 sales unit OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0712-2024.
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