DRG International, Inc. is recalling 504 units of its 17-OH Progesterone ELISA 96 well test kits (Model EIA-1292). The recall was initiated because the high and low control acceptance ranges on the component labels did not match the official Certificate of Analysis. This defect causes the device to fail to provide results, which may lead to testing delays. No incidents or injuries have been reported.
The labeling discrepancy causes the diagnostic device to fail to provide test results. This failure can result in a delay in obtaining critical medical information, posing a remote risk to patient health.
Lot Code: 04048474012927 (DRG Instruments GmbH)
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Sources: FDA iRES · Raw API Response
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