FDAClass IIApril 13, 2022

C-Peptide ELISA : IVD measurement of C-Peptide in serum recall

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

Why was C-Peptide ELISA : IVD measurement of C-Peptide in serum recalled?

ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible

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# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31

Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Recalling firm
DRG International, Inc.
Quantity
3 Kits
Distribution
NY
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls