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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S SYPHILIS REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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ABBOTT GMBH ALINITY S SYPHILIS REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 06P09-55
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
The customer noticed an increase in initial and repeat reactive rates for the alinity s syphilis assay in the months of (b)(6) 2021 and (b)(6) 2022 on both alinity s analyzers (as1076 and as1079) using the same lot numbers of reagent. The following are the total number of reactive results provided by the customer for (b)(6) 2021. Assay: new donor, returning donor (not previously reactive), returning donor (previously reactive). Syphilis: 2, 4, 2. The reactive results for the 4 donors that were previously nonreactive are considered to be potentially false reactive. No adverse impact to patient/donor management was reported.
 
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. All available patient information was included. Additional patient details are not available. This report is being filed on an international product, list number 06p09-55, that has a similar product distributed in the us, list number 08d06-31 and 08d06-41.
 
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Brand NameALINITY S SYPHILIS REAGENT KIT
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key13537162
MDR Text Key288382022
Report Number3002809144-2022-00058
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/27/2022
Device Catalogue Number06P09-55
Device Lot Number27526BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
Treatment
ALNTY S SYSTEM, 06P16-01, AS1076; ALNTY S SYSTEM, 06P16-01, AS1079
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