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PathTezt®
BIOCYTECH CORPORATION SDN. BHD. · Model PDR-1000 · UDI-DI 09551020410146
4
510(k) clearances
23
Adverse events
4
Recalls
24
Facilities
Description
Partially removes non-diagnostic debris and excess inflammatory cells increasing the detection of epithelial cell abnormalities from the sample.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | Hologic, Inc | Fungal contamination of affected lot with Parengyodontium album. |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o |
| 2012-02-20 | Leica Biosystems Richmond Inc. | Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 whic |
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