Recall Z-2150-2019— Randox Laboratories, Limited

Name: FDA recall Z-2150-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-11

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2019-06-11, terminated 2020-05-15. It names one FDA 510(k) clearance: K942458. 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.. Reason: 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..

Recalling firm: Randox Laboratories, Limited
Classification: Class II
Status: Terminated
Initiated: 2019-06-11
Terminated: 2020-05-15
Firm location: Crumlin, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K942458 — PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDRandox Laboratories, Ltd.·cleared 1995-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.