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C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasm...

FDA Recall #Z-0896-2022 — Class II — December 21, 2021

Recall #Z-0896-2022 Date: December 21, 2021 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

DRG International, Inc. — Springfield, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 Kits

Distribution

NY

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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