AUTOSTAT II IgM Rheumatoid Factor recall
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an…
Why was AUTOSTAT II IgM Rheumatoid Factor recalled?
Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.
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?
Lot Number 154962
- Product
- AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an…
- Recalling firm
- Hycor Biomedical Inc
- Quantity
- 207
- Distribution
- U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)