Food, drugs, devices › DRG Instruments GmbH
Device recall: Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estroge
DRG Instruments GmbH (Marburg) initiated this device recall on 14 Jul 2016; FDA lists 1 product record under event 80575, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 4 Aug 2020. Initiation: voluntary: firm initiated. DRG Instruments GmbH has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DRG Instruments GmbH, Marburg, Germany.
Reason for recall
"Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1."
Distribution
"NJ; Germany, Belgium, Spain & Germany"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2836-2018 | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva. | 169 kits | Class II | Terminated | 22 Aug 2018 |
Context
Other enforcement events for DRG Instruments GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Jun 2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro dia | Device | Class II | 1 |
| 21 May 2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: Th | Device | Class II | 1 |
All 3 events for DRG Instruments GmbH
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "NJ; Germany, Belgium, Spain & Germany"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.