Recall Z-2021-2023— Randox Laboratories Ltd.

Name: FDA recall Z-2021-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Class III · Ongoing

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2023-05-04. It names one FDA 510(k) clearance: K140522. Product: Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640. Reason: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range.

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Ongoing
Initiated: 2023-05-04
Firm location: Crumlin (North), N/A, Ireland

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 Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

Reason for recall

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

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