Z-2150-2019Class II

Human Assayed Multi-Sera Level 2, Model NO. HN1530

Name: Z-2150-2019 Human Assayed Multi-Sera Level 2, Model NO. HN1530
Creator: Randox Laboratories, Limited
Published: 2019-06-11
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-06-11 / Terminated

FDA source

Randox Laboratories, Limited began a recall of Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic... on 2019-06-11. FDA classified it as Class II and gives the reason as "The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2150-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-11
Posted: 2019-08-06
Terminated: 2020-05-15
Recalling firm: Randox Laboratories, Limited
Product: Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
FDA root cause: Under Investigation by firm
Action: On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following: " Review your reagent inventory of these products. Remove all previous versions of the Value Sheets in use and replace with the revised version. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to t echnical.services@ randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.
Quantity in commerce: 149 (US)
Distribution: US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
Product codes and lots: 1306UN, 1308UN, 1309UN

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2150-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2150-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code JJY

K942458Class IPrecision-Multi-Sera - Human - Normal and ElevatedRandox Laboratories, Ltd. / cleared 1995-03-13

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)