FDA Medical Device Recalls (openFDA)
Kamiya Biomedical Company, LLC: "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
- Recall number
- Z-0973-2010
- Recalling firm
- Kamiya Biomedical Company, LLC
- Product
- "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2009-05-01
- Posted
- 2010-03-04
- Terminated
- 2011-01-21
- Reason
- The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
- Root cause
- Other
- Action
- On May 1, 2009 the recalling firm, Kamiya Biomedical Company contacted the 3 consignees by telephone and notified them of the issue. A follow-up e-mail notification on May 4, 2009 was sent to consignees requesting to return the affected product to Kamiya Biomedical Company for a free replacement kit. After the e-mail notifications, an Urgent Medical Device Recall Notice dated May 13, 2009 was also sent to consignees describing the issue and actions to take for returning opened and unopened affected product to the recalling firm for replacement. Direct questions to the Kamiya Biomedical Company by calling 1- 206-575-8068.
- Quantity
- 3 kits each containing 5 x 2 ml vials
- Distribution
- United States (NY, NJ, and NC).
- Lot, serial or model codes
- Catalog number: "KAI-084C", Lot # "559011"
- 510(k) numbers
- ["K023828"]
- PMA numbers
- not on file
- Product code
- DCK
- Firm FEI
- 2084025
- Firm city
- Tukwila
- Firm state
- WA
- 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