Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Reported: July 4, 2018 Initiated: May 22, 2018 #Z-2279-2018
Product Description
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- 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.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683. Recalled by Randox Laboratories Ltd..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2279-2018.
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