NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs…
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The…
Read the official notice →- Date
- 2023-07-12
- Country
- United States
- Brand
- NeuMoDx Molecular
- Product
- NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs…
- Classification
- Class III
- Units
- US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 NeuMoDx Molecular recalls
- 2023-08-09
USNeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96…
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with…
FDA · DeviceNeuMoDx Molecular IncUS Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New…Official notice →- 2022-06-15
- US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and…
FDA · DeviceNeuMoDx Molecular IncDomestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution…Official notice → - 2022-05-04
- US
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test…
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu…
FDA · DeviceNeuMoDx Molecular IncWorldwide distribution - US Nationwide distribution in the states of OH, MO,…Official notice → - 2022-03-16
- US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in…
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MD, MI, NY.Official notice →
Other drugs & medical recalls in the United States
- 2023-07-12
- US
Pro-Dex Inc recalls KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be…
- US
TELEFLEX LLC recalls Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- US
CareFusion 303, Inc. recalls BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191,…
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.
FDA · DeviceCareFusion 303, Inc.US Nationwide-Worldwide Distribution: CO, MS, HI, FL, GA, CA, ND, GU, DE, MO,…Official notice → - US
Zimmer, Inc. recalls NexGen Precoat Stemmed Tibial Plate Size 5
Device outer packaging was incorrectly labeled.
- US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Storage and Retrieval Module (SRM)
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - US
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB…
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.