ALINITY M RESP-4-PLEX AMP KIT
Report
- Report Number
- 3005248192-2025-00064
- Event Type
- Malfunction
- Date Received
- March 25, 2025
- Date of Event
- February 24, 2025
- Report Date
- April 28, 2025
- Manufacturer
- ABBOTT MOLECULAR, INC.
- Product Code
- QJR
- UDI-DI
- 00884999049390
- Removal / Correction Number
- 3005248192-04/28/25-002-
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
THIS MDR IS BEING SUBMITTED IN ALIGNMENT WITH THE REQUIREMENTS IN THE LETTER OF AUTHORIZATION OF THE ALINITY M RESP-4-PLEX (B)(4), SECTION IV, CONDITION G THAT ABBOTT MOLECULAR WILL REPORT TO FDA ANY SUSPECTED SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT OF WHICH WE BECOME AWARE. AN INVESTIGATION IS IN PROCESS, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. ADDITIONAL LOTS ARE INCLUDED IN THIS MDR: 09N79-090, LOT 409383, D4: CATALOG NUMBER: 09N79-090, LOT NUMBER: 409383, UDI: (B)(4), H4: DEVICE MANUFACTURE DATE: 11/11/2024. 09N79-090, LOT 410627, D4: CATALOG NUMBER: 09N79-090, LOT NUMBER: 410627, EXPIRATION DATE: 01/03/2026, UDI: (B)(4), H4: DEVICE MANUFACTURE DATE: 01/15/2025. 09N79-090, LOT 411921, D4: CATALOG NUMBER: 09N79-090, LOT NUMBER: 411921, EXPIRATION DATE: 01/03/2026, UDI: (B)(4), H4: DEVICE MANUFACTURE DATE: 01/14/2025.
ON APRIL 21, 2025, A DECISION WAS MADE ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. FOR INCORRECT RSV AND FLUB RESULTS ON THE ALINITY M RESP-4-PLEX ASSAY, ASSOCIATED SEVERITY IS MODERATE. FIELD ACTION FA-AM-APR2025-307 WAS TAKEN TO ADDRESS THIS ISSUE AND WAS ISSUED ON APRIL 28, 2025. IT WAS DEEMED REPORTABLE PER 21CFR 806 (3005248192-04/28/25-002-R) AND THEREFORE WILL BE REPORTED UNDER 21CFR803 VIA THIS MDR WHICH WAS PREVIOUSLY SUBMITTED IN ALIGNMENT WITH THE REQUIREMENTS IN THE LETTER OF AUTHORIZATION OF THE ALINITY M RESP-4-PLEX EUA200572, SECTION IV, CONDITION G THAT ABBOTT MOLECULAR WILL REPORT TO FDA ANY SUSPECTED SIGNIFICANT DEVIATIONS FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT OF WHICH WE BECOME AWARE. ABBOTT HAS RECEIVED REPORTS OF AN INCREASE IN REACTIVE NEGATIVE CONTROLS AND FALSE POSITIVE RESULTS, WITH ALINITY M RESP-4-PLEX AMP KIT, LIST NUMBER 09N79-090 LOT NUMBERS 409383, 410627, AND 411921, AND LIST 09N79-096 LOT NUMBER 409384 ON THE ALINITY M SYSTEM. SPECIFICALLY, AN INCREASE IN THE AMOUNT OF REACTIVE NEGATIVE CONTROLS AND FALSE POSITIVE RESULTS HAVE BEEN REPORTED FOR THE RESPIRATORY SYNCYTIAL VIRUS (RSV) AND INFLUENZA B VIRUS (FLU B) AND TARGETS. BASED ON INTERNAL EVALUATION, FALSE POSITIVE RESULTS AND REACTIVE NEGATIVE CONTROLS MANIFEST AS A WEAK SIGNAL WITH A LATE CYCLE NUMBER FOR THESE TARGETS. INTERNAL EVALUATION HAS NOT SHOWN IMPACT TO INFLUENZA A VIRUS (FLU A) AND SARS TARGETS. THERE IS A POTENTIAL FOR DELAYED RESULTS AND FALSE POSITIVE RESULTS FOR RSV AND FLU B WHEN USING THESE LOTS. ALL SUBSEQUENT LOTS OF ALINITY M RESP-4-PLEX AMP KITS ARE NOT IMPACTED. CUSTOMERS WERE INFORMED TO DISCARD ANY REMAINING INVENTORY OF THE IMPACTED LOTS.
A NONCONFORMANCE (1031544) WAS OPENED ON FEB 24, 2025 FROM A REVIEW OF FIELD DATA ASSOCIATED WITH ALINITY M RESP-4-PLEX TESTING, WHICH DETERMINED THAT ALINITY M RESP- 4-PLEX AMP KIT, LIST NO. 09N79-090 LOTS 409383, 410627 AND 411921 AND 09N79-096, LOT 409384, WERE PRODUCING AN ELEVATED RATE OF REACTIVE NEGATIVE CONTROL (NC) FOR THE RSV ANALYTE. THE ALINITY M RESP-4-PLEX ASSAY IS A MULTIPLEX REAL-TIME REVERSE TRANSCRIPTION (RT) POLYMERASE CHAIN REACTION (PCR) TEST FOR USE WITH THE AUTOMATED ALINITY M SYSTEM FOR THE QUALITATIVE DETECTION AND DIFFERENTIATION OF RNA FROM FLU A, FLU B, RSV, AND SARS-COV-2 IN RESPIRATORY SPECIMENS FROM INDIVIDUALS SUSPECTED OF A RESPIRATORY VIRAL INFECTION CONSISTENT WITH COVID-19. PER THE FIELD REVIEW DATA, THE RSV NEGATIVE CONTROL REACTIVE RATE IS ABOVE THE ESTABLISHED PERFORMANCE CHARACTERISTIC OF LESS THAN OR EQUAL TO 2%.
PER NONCONFORMANCE QR (B)(4) AND MULTIPLE CONFIRMED ELEVATED COMPLAINT INVESTIGATIONS THERE HAS BEEN AN INCREASE IN NEGATIVE CONTROL RESPIRATORY SYNCYTIAL VIRUS (RSV) REACTIVITY OBSERVED IN RECENT RESP-4-PLEX AMP KITS RESULTING IN FALSE POSITIVE SAMPLES AND NEGATIVE CONTROL INVALIDS IN THE FIELD. A REVIEW OF FIELD DATA ASSOCIATED WITH ALINITY M RESP-4-PLEX TESTING DETERMINED THAT SELECT LOTS OF ALINITY M RESP-4-PLEX AMP KIT, LIST NO. 09N79-090 AND 09N79-096 WERE PRODUCING AN ELEVATED RATE OF REACTIVE NEGATIVE CONTROLS FOR THE RSV ANALYTE. RESP-4-PLEX ASSAY (9N79) BACKGROUND: THE ALINITY M RESP-4-PLEX ASSAY IS A MULTIPLEX REAL-TIME REVERSE TRANSCRIPTION (RT) POLYMERASE CHAIN REACTION (PCR) TEST FOR USE WITH THE AUTOMATED ALINITY M SYSTEM FOR THE QUALITATIVE DETECTION AND DIFFERENTIATION OF RNA FROM FLU A, FLU B, RSV, AND SARS-COV-2 IN RESPIRATORY SPECIMENS FROM INDIVIDUALS WITH SIGNS AND SYMPTOMS OF RESPIRATORY TRACT INFECTIONS. IMPACT ON PRODUCT FUNCTIONALITY: IMPACTED LOTS OF ALINITY M RESP-4-PLEX AMP KITS (LOTS 409383, 410627 AND 411921 (LIST 09N79-090) AND LOT 409384 (LIST 09N79-096)) INDICATE POTENTIAL CONTAMINATION WITH THE RSV TARGET AND MAY GENERATE DETECTED RESULTS FOR A SAMPLE OR CONTROL THAT DOES NOT CONTAIN THE RSV TARGET. A FALSE POSITIVE RESULT CAN EITHER CAUSE A DELAY OF RESULTS IF IT IS ON THE NEGATIVE CONTROL (NC) (CAUSING THE NC TO BE REACTIVE AND INVALIDATING THE RUN), OR AN INCORRECT RESULT IF IT IS ON A PATIENT SAMPLE. THE POTENTIAL HAZARDS IDENTIFIED FOR THIS COMPLAINT EVENT ARE INCORRECT RESULTS FOR RSV AND FLU B (FALSE POSITIVE) AND DELAY OF RESULTS (REACTIVE NC FOR RSV OR FLU B).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1132353 | ALINITY M RESP-4-PLEX AMP KIT | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT MOLECULAR, INC. | 409384 | 00884999049390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |