Recall Z-0812-2020 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
| Date | Dec 16, 2019 |
| Status | Terminated |
| Reason | The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer. |
| Root cause | Device Design |
| Action | Recall Letters was sent via email to all consignees regarding the correction on 12/16/2019 informing users of a new recommended hydration fluid which is reflected in labeling QC Sets and Panels: Technical Information TIB.2034 Rev G. Questions can be directed at Technical Support team at 1.320.229.7064 or techsupport@microbiologics.com . A response form is requested to be returned. |
| Quantity | 810 |
| Distribution | Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.