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CALAS Pronase
MERIDIAN BIOSCIENCE, INC. · Model 140050 · UDI-DI 00840733101083
GMD
Prescription
1
510(k) clearances
2
Adverse events
3
Recalls
7
Facilities
Description
CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-03 | Immuno-Mycologics, Inc | 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 sma |
| 2018-03-30 | Immuno-Mycologics, Inc | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results |
| 2016-12-27 | Immuno-Mycologics, Inc | The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who repo |
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