Recall Z-0932-2021— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-0932-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-22

Class III · Terminated

Class III FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2020-12-22, terminated 2021-07-20. It names one FDA 510(k) clearance: K001005. 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: 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..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class III
Status: Terminated
Initiated: 2020-12-22
Terminated: 2021-07-20
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K001005 — WAKO HDL-C/LDL-C CALIBRATORWako Chemicals USA, Inc.·cleared 2000-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.