Fujifilm Medical Systems U.S.A., Inc. Recall 87098
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 Medical Systems U.S.A., Inc. Recall 87098 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0932-2021 |
| Event ID | 87098 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of MO, OR, MD, PA. |
| Quantity | 10 boxes (4 units per box) |
| Recall 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. |
| Device Classification | 20210203 |
| Device Code Info | Lot EL629, Model 990-28011 |
| Center Classification Date | 20210128 |
| Recall Initiation Date | 20201222 |
| Recalling Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Initial Notification | |
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