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 Initiated
- December 22, 2020
- Terminated
- July 20, 2021
- Recall Number
- Z-0932-2021
- Quantity
- 10 boxes (4 units per box)
- Firm Location
- Lexington, MA
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.
Lot / Code Info
Lot EL629, Model 990-28011
Root Cause
Under Investigation by firm
Action Taken
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.
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