ZEUS ELISA Parvovirus B19 IgM Test System recall
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Why was ZEUS ELISA Parvovirus B19 IgM Test System recalled?
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
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?
UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239
- Product
- ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Recalling firm
- Zeus Scientific, Inc.
- Quantity
- 293 kits
- Distribution
- US States: CA, MA, MI, NJ, NY, TN, UT.
- Recall date
- December 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)