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U.S. Department of Health and Human Services

Class 2 Device Recall Calibration serum Level 3 (CAL 3)

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 Class 2 Device Recall Calibration serum Level 3 (CAL 3)see related information
Date Initiated by FirmMarch 05, 2024
Date PostedMay 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1759-2024
Recall Event ID 94358
510(K)NumberK053153 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductClinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Code Information Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information ContactLouise Lynn
028-94422413 Ext. 44
Manufacturer Reason
for Recall		Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
FDA Determined
Cause 2		Process design
ActionConsignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical services@randox.com within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to technical.services@randox.com.
Quantity in Commerce80,366 units (US: 242 units; OUS: 80,094 units)
DistributionDomestic: Nationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIX
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