MDx-Chex for BC-GP
STRECK, INC. · Model 250079 · UDI-DI 00844509002468
Description
MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-16 | Microbiologics Inc | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-01-31 | Microbiologics Inc | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs