Wako HDL-C/LDL-C Calibrator - Product Usage: designed recall
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…
Why was Wako HDL-C/LDL-C Calibrator - Product Usage: designed recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot EL629, Model 990-28011
- 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…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 10 boxes (4 units per box)
- Distribution
- US Nationwide distribution including in the states of MO, OR, MD, PA.
- Recall date
- February 3, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)