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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G IGG ANTI-HAV

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ABBOTT GMBH ARCHITECT HAVAB-G IGG ANTI-HAV Back to Search Results
Model Number 6L27-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 09/18/2019
Event Type  malfunction  
Manufacturer Narrative
Complete information: correction/removal reporting number
=
3002809144-11/08/19-011-r. The investigation into this issue is in process. A follow-up mdr will be submitted when the cause has been identified. A product recall letter was sent to all customers who have received shipment of the architect havab-g calibrator kit, lot 08219be00. The letter instructs the following: immediately discontinue use of the lot 08219be00 and to destroy any remaining inventory of the lot. Immediately contact customer support to order replacement material. Review the recall letter with their medical director or laboratory management and follow the laboratory protocol regarding the need for reviewing previously reported patient results. If any kits of this specific lot was forwarded to other laboratories, to notify that laboratory of the product recall and provide them a copy of the recall letter.
 
Event Description
Abbott laboratories has identified an issue during stability testing with the architect havab-g calibrator kit, list number 06l27-01; lot 08219be00, where this specific lot has the potential to be impacted by an increase in the relative light units (rlus) of up to 95%. With the increase in the calibrator rlu values, there is the potential for control values and patient results generated with the impacted calibrator lot to be decreased, which may change interpretations of results from reactive to falsely non-reactive. There has been no reported impact to patient management as a result of this issue.
 
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Brand NameARCHITECT HAVAB-G
Type of DeviceIGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9376289
MDR Text Key190118430
Report Number3002809144-2019-00825
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113704
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2020
Device Model Number6L27-01
Device Catalogue Number06L27-01
Device Lot Number08219BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number3002809144-11/08/19-011-

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