medical Class III Updated 2024-11-06

DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay

Recalled Product

17-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-1292


Hazard / Issue

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 provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.

Issued by

FDA

Affected States: AZ, CA, NH
Lot/Code Info: Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
View official government recall

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