EliA RF IgM Well recall
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid…
Why was EliA RF IgM Well recalled?
Potential for reporting low assay results
What should I do if I have this product?
Review the official FDA enforcement record for current 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) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
- Product
- EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid…
- Recalling firm
- Phadia Ab
- Quantity
- 30 kits
- Distribution
- US Nationwide n the states of NJ, NY, MI, WV, TX including PR
- Recall date
- July 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)