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Randox Liquid Assayed Specific Protein Control - Level 3… recallZ-2280-2018 · Randox Laboratories Ltd. · initiated May 22, 2018

Class II Terminated All recalls posted in June 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-2280-2018
Recall class
Class II
Status
Terminated
Initiated by the company
May 22, 2018
Posted by the FDA
Jun 13, 2018
Recalling firm
Randox Laboratories Ltd.
Product code
JJY
FDA submissions
K972608
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.

Product description

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

Code information (models, lots, serial numbers)

All lots.

Other devices under the same FDA submission

3 devices cleared under K972608 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80211).

Sources and updates

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