CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
DRG Salivary Progesterone HS Elisa- IVD recalled by DRG Instruments
DRG Instruments is recalling DRG Salivary Progesterone HS Elisa- IVD for the determination of progesterone in human. The recall was initiated on 6 Jun 2019 and the FDA has classified it as Class II.
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-2410-2019
- FDA event ID
- 83177
- Recalling firm
- DRG Instruments, Marburg, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2019
- FDA classified
- 27 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Jun 2019 | Recall initiated by company | |
| 27 Aug 2019 | Classified by FDA | +82 days |
| 4 Sep 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
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
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Where it was distributed
Distribution to Canada
Questions about this recall
Is DRG Salivary Progesterone HS Elisa- IVD for the determination of progesterone in human recalled?
Yes. DRG Instruments recalled DRG Salivary Progesterone HS Elisa- IVD for the determination of progesterone in human on 6 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2410-2019.
Why was it recalled?
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
Which lots are affected?
Lot Number:315K029
Where was it sold?
Distribution to Canada
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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