Dynex Technologies, Inc. recalls DYNEX Agility, Agility Analyzer, Model No. 67000
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the…
Read the official notice →- Date
- 2022-06-08
- Country
- United States
- Brand
- Dynex Technologies
- Product
- DYNEX Agility, Agility Analyzer, Model No. 67000
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Dynex Technologies recalls
- 2025-08-27
USDynex Technologies, Inc. recalls Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility…
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible…
Other drugs & medical recalls in the United States
- 2022-06-15
- US
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial)…
Failed Impurities/Degradation Specifications.
- 2022-06-08
- US
MicroPort Orthopedics Inc. recalls PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
FDA · DeviceMicroPort Orthopedics Inc.Worldwide distribution - US Nationwide distribution in the states of FL, IN,…Official notice → - US
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide distribution in the states of TX, CO,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- US
Tornier, Inc recalls Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
- US
Becton, Dickinson and Company, BD Biosciences recalls BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically…
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
FDA · DeviceBecton, Dickinson and Company, BD BiosciencesWorldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice →