Albumin BCP Product Usage: ALBP is an in vitro test recall
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi…
Why was Albumin BCP Product Usage: ALBP is an in vitro test recalled?
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
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?
Catalog Number 05975573190 Lot Number 35651401
- Product
- Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 774
- Distribution
- US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)