Recall Z-2279-2018
Randox Laboratories Ltd. · initiated May 22, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Codes / lots: All lots.
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2279-2018
- Initiated
- May 22, 2018
- Posted by FDA
- June 13, 2018
- Terminated
- November 17, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- 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…
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2278-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | 05/22/2018Terminated |
| Z-2280-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | 05/22/2018Terminated |