FDA-Device2018-07-04Class II
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Randox Laboratories Ltd.
Hazard
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.
Sold states
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.
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2018Don't want to check this manually?
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