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U.S. Department of Health and Human Services

Class 2 Device Recall Calibration Serum Level 3

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  Class 2 Device Recall Calibration Serum Level 3 see related information
Date Initiated by Firm November 13, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0751-2024
Recall Event ID 93602
510(K)Number K053153  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Code Information UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information Contact Louise Lynn
44-289-4422413
Manufacturer Reason
for Recall		 There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 20, 2023, the firm notified customers via Medical Device Correction letter. The letter consisted of three parts. This recall record covers the third part, which concerned transcription errors in the Instructions for Use (IFU) for the above listed products. Customers should discard all copies of the IFUs and download the latest versions from www.randox.com. Customers should discuss the contents of the recall notice with their Medical Director if they have used the incorrect target value for any of the affected products.
Distribution US Nationwide distribution.
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 = JIX and Original Applicant = RANDOX LABORATORIES, LTD.
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