Z-0973-2010

"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry...

Name: Z-0973-2010 "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry...
Creator: Kamiya Biomedical Company, LLC
Published: 2009-05-01
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2009-05-01 / Terminated

FDA source

Kamiya Biomedical Company, LLC began a recall of "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... on 2009-05-01. The reason FDA records is "The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0973-2010
Status: Terminated
Initiated: 2009-05-01
Posted: 2010-03-04
Terminated: 2011-01-21
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.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
FDA 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 in commerce: 3 kits each containing 5 x 2 ml vials
Distribution: United States (NY, NJ, and NC).
Product codes and lots: Catalog number: "KAI-084C", Lot # "559011"

Product code DCK

K023828Class IIK-Assay C-Reactive Protein (3), K-Assay Crp Multi-Calibrator D, K-Assay Crp Multi-Calibrator E, K-Assay Crp Multi-CalibrKamiya Biomedical Co. / cleared 2003-02-04

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)