Recall Z-0779-2017 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
PerkinElmer Health Sciences, Inc.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
| Date | Dec 16, 2016 (initiated Nov 16, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | PerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions. Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped. |
| Quantity | 79 kits |
| Distribution | CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862043 | DELFIA (TM) HFSH KIT Lkb Instruments, Inc., Jun 24, 1986 |