Recall Z-0970-2018— Randox Laboratories

Name: FDA recall Z-0970-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-11

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories, initiated 2017-08-11, terminated 2019-03-29. It names one FDA 510(k) clearance: K140522. Product: Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages). Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU..

Recalling firm: Randox Laboratories
Classification: Class III
Status: Terminated
Initiated: 2017-08-11
Terminated: 2019-03-29
Firm location: Kearneysville, WV, United States

510(k) clearances named in this recall

1 on FDA's record

K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROLRandox Laboratories Limited·cleared 2014-05-22

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

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Reason for recall

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

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