Z-2159-2019 Class II Terminated
FDA device recall Z-2159-2019 was initiated by DRG Instruments GmbH on May 21, 2019 and is designated Class II. Reason for recall: Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed signific… The recall status is terminated (terminated May 29, 2020). Affected quantity: 38 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- May 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 kits
Product Description
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Reason for Recall
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
Distribution Pattern
Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Code Information
Lot Numbers: 66K118, 66K019