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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELL MARQUE CORPORATION KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY

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CELL MARQUE CORPORATION KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY Back to Search Results
Model Number 274R
Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 06/25/2019
Event Type  malfunction  
Event Description
Cell marque purchased the correct material, kappa (ep171) however, the vendor shipped lambda (ep172). Review of purchase order showed the correct was ordered, kappa (ep171) from the supplier but the incorrect product was sent instead lambda (ep172). Review of customer complaints, 2 out of 3, were reporting and indicating that they were observing the same positive staining on the kappa as the lambda antibody. The customers questioned as to whether the material in the vials were accurate. Five finished product lots of kappa (ep171) rabbit monoclonal antibody were filled with lambda (ep172) rabbit monoclonal antibody. The lots affected were: 0000057589,0000057588,0000057618, 0000057617, 0000064775. Relevan part #s: 274r-14 - ruo, 274r-14, 274r-17, 274r-18 the product is therefore misbranded and the labeling does not represent the content.
 
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Brand NameKAPPA (EP171) RABBIT MONOCLONAL ANTIBODY
Type of DeviceKAPPA (EP171) RABBIT MONOCLONAL ANTIBODY
Manufacturer (Section D)
CELL MARQUE CORPORATION
6600 sierra college boulevard
rocklin CA 95677
MDR Report Key8848973
MDR Text Key217435977
Report Number1649339-2019-00001
Device Sequence Number1
Product Code NJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number274R
Device Catalogue Number274R
Device Lot Number57588, 64775, 57617, 57618
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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