AutoDELFIA¿ hCG Kit recall
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative…
Why was AutoDELFIA¿ hCG Kit recalled?
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
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?
Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
- Product
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative…
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Quantity
- 304 kits (United States)
- Distribution
- Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)