"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.
FDA Recall Z-0973-2010 · Posted 2010-03-04
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Recalling FirmKamiya Biomedical Company, LLC
Recall StatusTerminated
Product CodeDCK
Date Initiated2009-05-01
Date Terminated2011-01-21
Product Quantity3 kits each containing 5 x 2 ml vials
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.
Firm 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.
Root Cause
Other
Distribution Pattern
United States (NY, NJ, and NC).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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