Immuno-Mycologics, Inc recalls CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003,…
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive…
Read the official notice →- Date
- 2022-02-09
- Country
- United States
- Brand
- Immuno-Mycologics
- Product
- CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
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Siemens Medical Solutions USA, Inc. recalls ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
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Microbiologics Inc recalls KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
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Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
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DIXI MEDICAL USA recalls The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter…
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag