FDA Medical Device Recalls (openFDA)
DRG Instruments GmbH: DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
- Recall number
- Z-2410-2019
- Recalling firm
- DRG Instruments GmbH
- Product
- DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
- Status
- Terminated
- Initiated
- 2019-06-06
- Posted
- not on file
- Terminated
- 2020-05-11
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- DRG International issued notification letter via email dated 5/22/19 advising of the problem, health risk and Action to be taken by Distributors and End-users: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products. 2. Please send back or discard all unused kits 3. Please use the attached response form, fill, sign and send back to us 4. Please inform your customers and forward this letter and notice to persons who received the affected lot and request they fill out the form and return at once. 5. Patient samples that have been determined with the affected lot should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: qa@drg-international.com and copy drgsupport.@drginternational.com).
- Quantity
- 8 Kits
- Distribution
- Distribution to Canada
- Lot, serial or model codes
- Lot Number:315K029
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JLS
- Firm FEI
- 3002800697
- Firm city
- Marburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28