MULTIGENT Creatinine recall
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum…
Why was MULTIGENT Creatinine recalled?
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
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 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
- Product
- MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum…
- Recalling firm
- Sentinel CH SPA
- Quantity
- 2356 kits Worldwide; US 206 kits
- Distribution
- Nationwide Distribution
- Recall date
- August 9, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)