Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing,…
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration…
Read the official notice →- Date
- 2023-02-01
- Country
- United States
- Brand
- Abbott Molecular
- Product
- Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing,…
- Classification
- Class II
- Units
- x
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abbott Molecular recalls
- 2024-03-06
USAbbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.Official notice →- 2023-12-06
- US
Abbott Molecular, Inc. recalls Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse…
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
- 2023-04-12
- US
Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This…
FDA · DeviceAbbott Molecular, Inc.US Distribution to state of: PA, a government account.Official notice → - 2022-12-28
- US
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- 2022-11-30
- US
Abbott Molecular, Inc. recalls Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and…
- 2022-09-14
- US
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA · DeviceAbbott Molecular, Inc.Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO,…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-01
- US
CooperVision, Inc. recalls MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
FDA · DeviceCooperVision, Inc.Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Electrocardiograph, ELI 380 -DCS21
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- US
TELEFLEX LLC recalls Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube…
Potential for pilot balloon non-inflation or cuff non-deflation.
FDA · DeviceTELEFLEX LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Meridian Bioscience Inc recalls Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN,…Official notice → - US
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France,…Official notice → - US
Agfa Healthcare NV recalls Agfa HealthCare Enterprise Imaging XERO Viewer
There is a software defect that can cause issues with images.
FDA · DeviceAgfa Healthcare NVDistribution throughout US OUS distribution to Australia, Belgium, Brazil,…Official notice →