FDA Medical Device Recalls (openFDA)
PerkinElmer Health Sciences, Inc.: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
- Recall number
- Z-0779-2017
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Product
- DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
- Status
- Terminated
- Initiated
- 2016-11-16
- Posted
- 2016-12-16
- Terminated
- 2017-07-05
- 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,
- Lot, serial or model codes
- Lot Number: 646091
- 510(k) numbers
- ["K862043"]
- PMA numbers
- not on file
- Product code
- CGJ
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28