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Mucolyse (10x100 mg)
PRO-LAB, INCORPORATED · Model PL.701 · UDI-DI 20628429001008
10
510(k) clearances
19
Adverse events
6
Recalls
15
Facilities
Description
Mucolyse presents an effective sputum digestant supplied in a simple, convenient, economical and safe format. Each vial, containing lyophilised predetermined quantities of Dithiothreitol and Phosphate Buffer, reconstitutes with 10 ml of sterile water, and then dilutes to 100 ml of active digestant solution.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-11 | Acumedia Manufacturers, Inc. | Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. |
| 2015-02-05 | Remel Inc | Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila. |
| 2014-11-13 | Remel Inc | Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting. |
| 2014-10-17 | Remel Inc | Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila. |
| 2014-01-24 | Remel Inc | The product may contain high levels of microbial contamination |
| 2012-10-10 | Remel Inc | The product may contain low level microbial contamination which could result in incorrect results. |
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