SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C

FDA device recall Z-0624-2024 · posted 2024-01-02 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

Action taken

Randox issued Urgent Medical Device Correction Letter on 11/6/23 to the US Distributor Randox Laboratories-US, Ltd. , Kearneysville, West Virginia, for issuance to the user level. Letter states reason for recall, health risk and action to take: As the control material is still testing positive for HSV Type 1/2 lgM, there is no risk to health. If the control did test negative for this analyte, the affected run should be discarded, and the samples re-analysed. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFU and download the latest version from www.randox.com.alth risk and action to take: (

Root cause

Process control

Status

Open, Classified

Product code

OHQ

Quantity affected

1 unit

Distribution

NY, WV

Date initiated

2023-11-06

Date posted

2024-01-02

Location

Crumlin, North, Ireland