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.
Z-0932-2021
Product summary
- Event
- Event 87098
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10 boxes (4 units per box)
- Official record key
device-enforcement:Z-0932-2021
Official wording
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.
Code information: Lot EL629, Model 990-28011
Distribution pattern: US Nationwide distribution including in the states of MO, OR, MD, PA.
Derived failure modes
-
Potency or specification failure
incorrect concentration