lmmunalysis EDDP Urine Control Set 1 The EDDP Urine recall
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP…
Why was lmmunalysis EDDP Urine Control Set 1 The EDDP Urine recalled?
The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.
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?
Part Number: 3006-5, Lot Number: EK16135
- Product
- lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP…
- Recalling firm
- Alere San Diego Inc. DBA Immunalysis Corporation
- Quantity
- 37 kits
- Distribution
- US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
- Recall date
- June 20, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)