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Terminated

Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

FDA Recall Z-2280-2018 · Posted 2018-06-13

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJJY
Date Initiated2018-05-22
Date Terminated2020-11-17

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.

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 [email protected] within five working days. If you have any questions after reviewing this information, you may contact the firm at [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLRandox Laboratories, Ltd. · 1997-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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