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…
Read the official notice →- Date
- 2022-11-30
- Country
- United States
- Brand
- Abbott Molecular
- Product
- Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
- Classification
- Class II
- Units
- Worldwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-04-12
USAbbott 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 →- 2023-02-01
- US
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…
- 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.
- 2022-09-14
- 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 → - 2022-08-24
- US
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Incorrect optical calibration
- 2022-04-13
- US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice →
Other drugs & medical recalls in the United States
- 2022-11-30
- US
Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
FDA · DeviceKamiya Biomedical Company, LLCWorldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA,…Official notice → - US
Endo-Therapeutics, Inc. recalls eSuction Small Cavity, Model ET2005
Improper device regulatory classification
- US
Beckman Coulter, Inc. recalls MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI…Official notice → - US
Hamilton Medical AG recalls Hamilton-C6
Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
FDA · DeviceHamilton Medical AGU.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN,…Official notice → - US
Allison Medical, Inc. recalls InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Insulin syringe retail packages incorrectly labeled as "Short Needle".
- US
Medical Action Industries, Inc. 306 recalls B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected…
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
FDA · DeviceMedical Action Industries, Inc. 306US Nationwide distribution in the state of Pennsylvania.Official notice →