Recall Z-0779-2017— PerkinElmer Health Sciences, Inc.
Class III · Terminated
Class III FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2016-11-16, terminated 2017-07-05. It names one FDA 510(k) clearance: K862043. Product: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum. Reason: 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..
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-11-16
- Terminated
- 2017-07-05
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.