Reported Dec 28, 2016 · Terminated
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
PerkinElmer Health Sciences, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PerkinElmer Health Sciences, Inc. · 940 Winter St · Waltham, MA · 02451-1457
Is this the product you have?
- DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
- Lot codes and dates
- Lot Number646091
- Amount recalled
- 79 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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