Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2,…
Due to a software issue
Read the official notice →- Date
- 2026-09-23
- Country
- United States
- Brand
- Nuclein
- Product
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Alabama, Delaware, Florida,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Nuclein recalls
- 2026-08-12
USNuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2…
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
- 2025-08-13
- US
Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is…
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
FDA · DeviceNuclein LLCUS distribution to: Florida, New York, Texas, and West VirginiaOfficial notice →
Other drugs & medical recalls in the United States
- 2026-09-23
- US
WELL LEAD MEDICAL CO. LTD recalls SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
The 6Fr suction catheter could not pass through the samples smoothly.
FDA · DeviceWELL LEAD MEDICAL CO. LTDUS Nationwide distribution in the state of MI.Official notice → - US
GE Healthcare recalls Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient…
- US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- US
ICU Medical, Inc. recalls Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states and territories…Official notice → - US
AVID Medical, Inc. recalls Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
FDA · DeviceAbiomed, Inc.Domestic: Nationwide Distribution. International: United Arab Emirates,…Official notice →