|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (R...
|
2
|
05/12/2025
|
Abbott Molecular, Inc.
|
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time rev...
|
2
|
05/12/2025
|
Abbott Molecular, Inc.
|
Cardinal Health Presource Kits:
1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11;
2) CHI STD SPI...
|
2
|
02/10/2025
|
Cardinal Health 200, LLC
|
BD PCR Cartridges used with MAX System. Model Number: 437519
|
2
|
01/21/2025
|
Becton Dickinson & Co.
|
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngea...
|
2
|
06/05/2024
|
Becton Dickinson & Co.
|
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for ...
|
2
|
01/10/2024
|
BioFire Diagnostics, LLC
|
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes:
a) QS6 A...
|
2
|
01/10/2024
|
Baxter Healthcare Corporation
|
XScribe Cardiac Stress Testing System, version 6, with below product names and codes:
a) XS6/RS6 REV...
|
2
|
01/10/2024
|
Baxter Healthcare Corporation
|
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay i...
|
2
|
11/29/2023
|
Abbott Molecular, Inc.
|
Procedure packs:
(1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile;
(2) Presource PBDS Cat. POC...
|
2
|
10/10/2023
|
Cardinal Health 200, LLC
|