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.
Recall
- Recall Number
- Z-0932-2021
- Event Number
- 87098
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- FEI Number
- 1000513161
- Product Code
- JIS
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 22, 2020
- Terminated
- July 20, 2021
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160
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.
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.
On, 12/22/2020, FUJIFILM issued an Urgent Medical Device Removal notice to customers via email. Incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result in incorrect results when used in testing.
US Nationwide distribution including in the states of MO, OR, MD, PA.
10 boxes (4 units per box)