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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2)

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 Class 2 Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2)see related information
Date Initiated by FirmMay 22, 2018
Date PostedJune 13, 2018
Recall Status1 Terminated 3 on November 17, 2020
Recall NumberZ-2279-2018
Recall Event ID 80211
510(K)NumberK972608 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductRandox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Code Information All lots.
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information ContactMariclare Ferguson
44-289-4422413
Manufacturer Reason
for Recall		The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn May 22, 2018, Randox issued an Urgent Field Safety Notice to affected distributors along with an Important Notice and updated IFU. The letter advised customers of the product issue. It further instructed distributors to do the following: 1. Discuss the contents of the notice with your Medical Director. 2. Place a copy of the important notice and updated IFU into any remaining stock. 3. Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. If you have any questions after reviewing this information, you may contact the firm at technical.services@randox.com.
DistributionDistributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJY
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