Salivary Testosterone ELISA recall
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro…
Why was Salivary Testosterone ELISA 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
- Product
- Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro…
- Recalling firm
- DRG International, Inc.
- Quantity
- 257 units
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Recall date
- August 21, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)