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U.S. Department of Health and Human Services

Class 2 Device Recall LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1, 2 AND 3

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 Class 2 Device Recall LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1, 2 AND 3see related information
Date Initiated by FirmFebruary 18, 2020
Create DateMarch 20, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1547-2020
Recall Event ID 85030
510(K)NumberK140971 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductChemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Code Information Lot 306UL
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information ContactRandox Technical Services
866-4726369
Manufacturer Reason
for Recall		The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 18, 2020, the firm notified customers of the action via emailed Urgent Medical Device Correction letters. Customers were informed of the incorrectly assigned control target and range value for Sodium using the ISE indirect method. The letter stated that the sections for Roche Cobas series and mean of all instruments has now been updated, and the updated value sheets were included with the email. The updated value sheets may also be found on www.randox.com. Customers were asked to take the following actions: - Review results generated with the affected batches in line with the clinical profile of the patient. -Discuss the contents of the notice with your Medical Director. -Complete and return the included response form within 5 working days. Distributors were asked to forward a copy of the notice to all affected customers. If you have questions or concerns, please contact Randox Technical Services: 866-4-RANDOX, or customersupportusa@randox.com
Quantity in Commerce186 total, 27 USA
DistributionWorldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.
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 = JJY
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