Recall Z-0762-2017— Randox Laboratories

Name: FDA recall Z-0762-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-16

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories, initiated 2016-09-16, terminated 2018-04-11. It names one FDA 510(k) clearance: K110534. Product: The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.. Reason: An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods..

Recalling firm: Randox Laboratories
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Terminated: 2018-04-11
Firm location: Antrim, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3Randox Laboratories Limited·cleared 2012-01-23

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

The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

Reason for recall

An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.

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