Reported Nov 6, 2024 · Ongoing
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of…
DRG International, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DRG International, Inc. · 841 Mountain Ave · Springfield, NJ · 07081-3437
Is this the product you have?
- 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 NumberEIA-1292
- Lot codes and dates
- Lot Code04048474012927 (DRG
- Instruments GmbH) lots22K024 and 22K034
- Amount recalled
- 504 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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