Z-1547-2020Class II

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 -

Name: Z-1547-2020 Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 -
Creator: Randox Laboratories Ltd.
Published: 2020-02-18
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-02-18 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control... on 2020-02-18. FDA classified it as Class II and gives the reason as "The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1547-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-18
Posted: 2020-03-20
Recalling firm: Randox Laboratories, Limited
Product: Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
FDA root cause: Under Investigation by firm
Action: On February 18, 2020, the firm notified customers of the action via emailed Urgent Medical Device Correction letters. Customers were informed of the incorrectly assigned control target and range value for Sodium using the ISE indirect method. The letter stated that the sections for Roche Cobas series and mean of all instruments has now been updated, and the updated value sheets were included with the email. The updated value sheets may also be found on www.randox.com. Customers were asked to take the following actions: - Review results generated with the affected batches in line with the clinical profile of the patient. -Discuss the contents of the notice with your Medical Director. -Complete and return the included response form within 5 working days. Distributors were asked to forward a copy of the notice to all affected customers. If you have questions or concerns, please contact Randox Technical Services: 866-4-RANDOX, or [email protected]
Quantity in commerce: 186 total, 27 USA
Distribution: Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.
Product codes and lots: Lot 306UL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1547-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1547-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code JJY

K140971Class ILiquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited / cleared 2014-12-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)