Kamiya Biomedical Company 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Kamiya Biomedical Company
Lot Codes / Batch Numbers
Lot No.: 666011 EXP.: 07/2007
Products Sold
Lot No.: 666011 EXP.: 07/2007
Kamiya Biomedical Company is recalling K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 due to Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026