FDA recall Z-0932-2021

Fujifilm Medical Systems U.S.A., Inc. · Class III · device

Product

Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

Reason for recall

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

Distribution

US Nationwide distribution including in the states of MO, OR, MD, PA.

Key facts

Status
Terminated
Initiation date
2020-12-22
Report date
2021-02-03
Termination date
2021-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0932-2021