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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION Back to Search Results
Catalog Number 7D2648
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.H3 other text : device discarded, single use.
 
Event Description
The customer reported an unknown number of false positive with determine hiv 1/2 ag/ab combo 25t on (b)(6) 2023.Attempts were made to gather more information, but the customer has been unresponsive.No additional patient information, including treatment and outcome, was provided.
 
Event Description
The customer reported an unknow number of false positive with determine hiv 1/2 ag/ab combo 25t on unknown dates.Attempts were made to gather more information, but the customer has been unresponsive.No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.B3: the date provided is an approximation as the exact event dates were not provided.
 
Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : device discarded, single use.
 
Event Description
The customer reported an unknow number of false positive with determine hiv 1/2 ag/ab combo 25t on (b)(6) 2023.Attempts were made to gather more information, but the customer has been unresponsive.No additional patient information, including treatment and outcome, was provided.
 
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Brand Name
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
Type of Device
TEST, HIV DETECTION
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key17061432
MDR Text Key316734914
Report Number1221359-2023-01195
Device Sequence Number1
Product Code MZF
UDI-Device Identifier00811877011101
UDI-Public00811877011101
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BP120037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/21/2023
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
Device Operator Health Professional
Device Catalogue Number7D2648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2023
Initial Date FDA Received06/05/2023
Supplement Dates Manufacturer Received06/19/2023
06/21/2023
Supplement Dates FDA Received06/19/2023
06/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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