C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog #
Summary
The FDA issued a Class II for C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- by DRG International, Inc.. Reason: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible.
Details
Source
Device Recall
External ID
Z-0896-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Lot/Code Info: Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Quantity Affected: 3 Kits
Reason for Recall
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Distribution
NY
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-21
Company
Springfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRG International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRG International, Inc. have FDA actions?
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0896-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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