DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- DRG
- Product
- C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
- Classification
- Class II
- Units
- NY
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More DRG recalls
- 2026-10-14
US
DRG International, Inc. recalls Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Potential for false negative patient results.
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice →- 2025-08-13
US
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the states of CA, MA, PA and the…Official notice →- 2025-01-22
US
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High)…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of New Jersey and the…Official notice →- 2024-11-06
US
DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone…
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to…
FDA · DeviceDRG International, Inc.AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy…Official notice →- 2024-08-21
US
DRG International, Inc. recalls Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative…
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
FDA · DeviceDRG International, Inc.US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.Official notice →- 2021-12-08
US
DRG International, Inc. recalls Total Thyroxine (T4) ELISA; REF EIA-1781
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
FDA · DeviceDRG International, Inc.Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-14
US
Rae Wellness Recalls Prenatal and Immunity Dietary Supplements Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products are dietary supplements containing iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a…
- 2022-04-13
US
MEDLINE INDUSTRIES, LP - Northfield recalls Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV…
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide Distribution was made to KY, OK, and TX. There was no…Official notice →US
Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump…
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly,…
FDA · DeviceMaquet Medical Systems USAUS Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium,…Official notice →US
Abbott recalls Amplatzer Steerable Delivery Sheath
Instructions for use were updated.
US
Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
FDA · DeviceVentana Medical Systems IncUS: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND,…Official notice →US
Siemens Medical Solutions USA, Inc. recalls Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.Official notice →