510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DRG International, Inc.

Springfield, NJ, US

DRG International, Inc. appears in FDA device records in Springfield, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
8
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for DRG International, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
22452852245285DRG International, Inc.841 Mountain Ave, Springfield, NJ 07081 US2026and 88 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2265-2025Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISAAn 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 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).Class IIIOpen, Classified
Z-0921-2025DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361The 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) which causes a delay in results.Class IIOpen, Classified
Z-0258-202517-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292The 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 provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.Class IIIOpen, Classified
Z-2622-2024Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.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.Class IIIOpen, Classified
Z-0896-2022C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possibleClass IITerminated
Z-0310-2022Total Thyroxine (T4) ELISA; REF EIA-1781Firm 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.Class IIOpen, Classified
Z-1068-2010CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.Terminated
Z-1067-2010CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain