Entopsis , Inc. recalls PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000…
Presence of misleading label statements on the product label.
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Entopsis , Inc.
- Product
- PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000…
- Classification
- Class II
- Units
- Nationwide and Canada, UK, Portugal, England, Spain, England , Germany,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2023-04-05
USQuidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
- US
Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Albania,…Official notice → - US
Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - US
Zimmer, Inc. recalls CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item…
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the…
- US
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
FDA · DeviceIntuitive Surgical, Inc.U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.:…Official notice → - US
Brainlab AG recalls Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device