CLASS III ONGOING Device recall · Reported 21 Aug 2024 · FDA Enforcement Report
Salivary Testosterone Elisa recalled by DRG International
DRG International is recalling Salivary Testosterone Elisa, distributed nationwide in the US. The recall was initiated on 5 Jul 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2622-2024
- FDA event ID
- 95021
- Recalling firm
- DRG International, Springfield, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 5 Jul 2024
- FDA classified
- 15 Aug 2024
- Reported
- 21 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jul 2024 | Recall initiated by company | |
| 15 Aug 2024 | Classified by FDA | +41 days |
| 21 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Product 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.
Where it was distributed
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Nationwide CaliforniaIllinoisMinnesotaPennsylvaniaUtahVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
Where was it sold?
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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