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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-G; IGG ANTI-HAV
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ABBOTT GERMANY ARCHITECT HAVAB-G; IGG ANTI-HAV Back to Search Results
Catalog Number 06C29-27
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2018
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product list 6c29, that has a similar us product distributed in the us, list 6l27.Patient identifier of multiple are ids: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6).The evaluation is in process.A follow up report will be submitted when the evaluation is complete.
 
Event Description
The account observed (b)(6) architect havab-igg results with 9 samples (ids (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6)) during (b)(6) through (b)(6) 2018, that repeated (b)(6) using another reagent lot.No specific patient information provided.No impact to patient management was reported.
 
Manufacturer Narrative
The event documented has been associated with a product recall.The event associated with the suspect medical device architect havab igg reagents is not reportable per 21cfr part 806, as the product has not been distributed in the us.No further follow ups will be provided for this event.
 
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Brand Name
ARCHITECT HAVAB-G
Type of Device
IGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8371453
MDR Text Key137285510
Report Number3002809144-2019-00073
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06C29-27
Device Lot Number87317LI00
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR LIST 03M74-97; ARCHITECT I2000SR LIST 03M74-97; SERIAL ISR01575; SERIAL ISR01575
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