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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB IGG; IGG ANTI-HAV
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ABBOTT GERMANY ARCHITECT HAVAB IGG; IGG ANTI-HAV Back to Search Results
Catalog Number 06C29-27
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, list 06c29 that has a similar product distributed in the us, list number 06l27.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a (b)(6) architect havab igg the customer provided the following data: the patient was first tested on (b)(6) 2018: sid (b)(6) result (b)(6).The patient was retested on (b)(6) 2018: sid (b)(6) result (b)(6).There was no adverse impact to patient management 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 up reports will be provided for this event.
 
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Brand Name
ARCHITECT HAVAB IGG
Type of Device
IGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8152455
MDR Text Key131307236
Report Number3002809144-2018-00543
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 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
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? Yes
Date Manufacturer Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALZER; ARCHITECT I2000SR ANALZYER; LN 03M74-02, SN (B)(4); LN 03M74-02, SN (B)(4)
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