DELFIA hFSH kit — Class III medical device recall Z-0779-2017
Terminated recall by PerkinElmer Health Sciences, Inc., reported 2016-12-28, distributed in CA, CO, NY, WA. A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease
| Recall number | Z-0779-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences, Inc., Waltham, MA, United States |
| Recall initiated | 2016-11-16 |
| Classified | 2016-12-16 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-07-05 |
| Distributed | CA, CO, NY, WA |
| Countries outside the US | AT, BO, GB, JP, NL, NO, SE |
| Quantity | 79 kits |
| Reason classes | potency, specification failure |
| Lot numbers | 646091 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0779-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.