Recall Z-0932-2021 ยท JIS Calibrator, Primary
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Dec 22, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 10 boxes (4 units per box) |
| Distribution | US Nationwide distribution including in the states of MO, OR, MD, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001005 | WAKO HDL-C/LDL-C CALIBRATOR Wako Chemicals USA, Inc., Jun 1, 2000 |