Recall Z-1785-2019— Randox Laboratories Ltd.

Name: FDA recall Z-1785-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-11

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2019-03-11, terminated 2020-05-15. It names one FDA 510(k) clearance: K110534. Product: Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053. Reason: Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2019-03-11
Terminated: 2020-05-15
Firm location: Crumlin (North), N/A, Ireland

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

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

Reason for recall

Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.

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