DELFIA hFSH kit. In Vitro Diagnostic for the recall
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Why was DELFIA hFSH kit. In Vitro Diagnostic for the recalled?
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
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: 646091
- Product
- DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Quantity
- 79 kits
- Distribution
- CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
- Recall date
- December 28, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)