Reported Aug 21, 2024 · Ongoing
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for…
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?
- Product NameSalivary
- Testosterone ELISA Model/Catalog NumberSLV-3013
- Product DescriptionAn enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva
- Lot codes and dates
- Model/Catalog NumberSLV-3013
- UDI-DI04048474030136
- Lot Nymbers66K014 and 66K123
- Amount recalled
- 257 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new DRG International, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.