Recall Z-0624-2024
Randox Laboratories Ltd. · initiated November 6, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
Codes / lots: GTIN: 05055273216424 Bath/Lot Number: 157SR
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.
FDA-determined cause: Process control
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: (
Details
- Recall number
- Z-0624-2024
- Initiated
- November 6, 2023
- Posted by FDA
- January 2, 2024
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 1 unit
- Distribution
- NY, WV
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North