FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
- Recall number
- Z-3118-2017
- Recalling firm
- Beckman Coulter Inc.
- Product
- Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
- Status
- Terminated
- Initiated
- 2017-07-20
- Posted
- not on file
- Terminated
- 2018-01-04
- Reason
- Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters dated 7/17/2017 via regular mail and email on 7/20/2017 to all customers receiving the affected product.
- Quantity
- 320 units
- Distribution
- Distribution US nationwide.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K081938"]
- PMA numbers
- not on file
- Product code
- LDP
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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