Z-2278-2018Class II

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

Name: Z-2278-2018 Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
Creator: Randox Laboratories Ltd.
Published: 2018-05-22
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-05-22 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682 on 2018-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2278-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-22
Posted: 2018-06-13
Terminated: 2020-11-17
Recalling firm: Randox Laboratories, Limited
Product: Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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 root cause: Under Investigation by 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].
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 codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2278-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2278-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2279-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2280-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22

Product code JJY

K972608Class IRandox Assayed Specific Protein ControlRandox Laboratories, Ltd. / cleared 1997-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)