Recall Z-0937-2018— Randox Laboratories, Limited

Name: FDA recall Z-0937-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-08

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2017-08-08, terminated 2018-09-05. It names one FDA 510(k) clearance: K110534. Product: Liquid Cardiac Control CQ5053. Reason: Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field..

Recalling firm: Randox Laboratories, Limited
Classification: Class II
Status: Terminated
Initiated: 2017-08-08
Terminated: 2018-09-05
Firm location: Crumlin, 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

Liquid Cardiac Control CQ5053

Reason for recall

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

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