Z-0850-06

K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One...

Name: Z-0850-06 K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One...
Creator: Kamiya Biomedical Company
Published: 2006-04-11
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2006-04-11 / Terminated

FDA source

Kamiya Biomedical Company began a recall of K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM... on 2006-04-11. The reason FDA records is "Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0850-06
Status: Terminated
Initiated: 2006-04-11
Posted: 2006-05-06
Terminated: 2006-05-16
Recalling firm: Kamiya Biomedical Company, LLC
Product: K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent
FDA root cause: Other
Action: Customers were contacted via telephone on 4/11/06. Customers were asked to confirm the number of kits in their possession and then open the kits to verify which vials they received in their kits. If the kits contained both vials, then the customer was instructed to keep the kit. If the kits contained the wrong vials, then they were requested to return the kits. This was followed by a letter dated 4/17/06. The letter confirmed the telephone call and asked the customer to sign and return the letter to acknoweldge receipt of the letter.
Quantity in commerce: 185 kits
Distribution: Kits were distributed to laboratories nationwide. One foreign account in Singapore.
Product codes and lots: Lot No.: 666011 EXP.: 07/2007

Product code DCK

K992312Class IIK-Assay Crp (2), K-Assay Crp Multi-Calibrator a, K-Assay Crp Multi-Calibrator BKamiya Biomedical Co. / cleared 1999-09-13

MDM coverage of this record lists here, newest first.

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)