| Class 2 Device Recall Randox Liquid Assayed Specific Protein Control Level 3 (SP Control 3) | |
Date Initiated by Firm | May 22, 2018 |
Date Posted | June 13, 2018 |
Recall Status1 |
Terminated 3 on November 17, 2020 |
Recall Number | Z-2280-2018 |
Recall Event ID |
80211 |
510(K)Number | K972608 |
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
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Product | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684 |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
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For Additional Information Contact | Mariclare 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 |
Action | On 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. |
Distribution | Distributed 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 Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JJY
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