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U.S. Department of Health and Human Services

Class 2 Device Recall QMS Tacrolimus Calibrators

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  Class 2 Device Recall QMS Tacrolimus Calibrators see related information
Date Initiated by Firm November 21, 2023
Date Posted January 11, 2024
Recall Status1 Open3, Classified
Recall Number Z-0712-2024
Recall Event ID 93621
510(K)Number K123343  
Product Classification Calibrator, secondary - Product Code JIT
Product QMS Tacrolimus Calibrators, Product code 10015573
Code Information No UDI Lot 74859619, Expiry 11-May-2024
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Mr. Joe Falvo
585-453-3000
Manufacturer 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.
FDA Determined
Cause 2		 Storage
Action On 21 November 2023, all consignees who were shipped the VITROS QMS Tacrolimus Calibrators Lot 74859619 expiry date: 11-May-2024 from QuidelOrtho distribution center were notified of the issue and instructed to: -Discontinue using, render unusable, and discard your inventory of QMS Tacrolimus Calibrators, Lot 74859619, which was shipped to the laboratory from QuidelOrtho. -Post the notification by the laboratory s inventory storage area until a replacement lot of QMS Tacrolimus Calibrator has been received. -Forward the notification if the affected product was distributed outside their facility. If you have questions about this recall, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.
Quantity in Commerce 10 sales units US; 1 sales unit OUS
Distribution Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JIT and Original Applicant = MICROGENICS CORP.
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