FDA recall Z-0362-2023

Product

IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

Reason for recall

Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

Distribution

US Nationwide Distribution: CA, NC, NJ and WV,

Key facts

Status

Terminated

Initiation date

2022-11-01

Report date

2022-12-14

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2023