FDA recall Z-1500-2020

Product

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

Reason for recall

It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

Distribution

Distributed in CA.

Key facts

Status

Terminated

Initiation date

2019-11-06

Report date

2020-03-25

Termination date

2022-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2020