MAUDE Adverse Event Report: CELLESTIS INC. CELLESTIS; QUANTIFERON TB GOLD

Catalog Number	T0592-0201
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a capa investigation, historical complaints were found that were identified as requiring a medwatch report.The company has decided to submit this mdr for information purposes to ensure full compliance with 21cfr part 803.Cellestis filed notification of their voluntary recall through the regional fda district recall office on 16oct2012.Closure of the recall by the fda was received 25apr2013.
Event or Problem Description
Cellestis customer complaint #(b)(4) was received that states throughout the month of (b)(6) 2012 the customer was seeing a dramatic increase in positive results, where the previous qft test was negative with no risk factors.Previous months did not show a significant increase as did (b)(6).Product associated with this complaint was found to be malfunctioning and subsequently recalled (recall reference #(b)(4)).

• Brand Name: CELLESTIS
• Common Device Name: QUANTIFERON TB GOLD
• Manufacturer (Section D): CELLESTIS INC.; 28358 constellation road; unit 698; valencia CA 91355
• MDR Report Key: 5408477
• Report Number: 1122376-2016-00001
• Device Sequence Number: 245533
• Product Code: NCD
• UDI-Device Identifier: 04053228002109
• UDI-Public: 04053228002109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Report Date (Section B): 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Medical Technologist
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: T0592-0201
• Device Lot Number: A111103N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003964343-01/28/13-001R
• Patient Sequence Number: 1