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Prolex Strep Enzyme Kit
PRO-LAB, INCORPORATED · Model PL.1050 · UDI-DI 10628429001377
10
510(k) clearances
39
Adverse events
3
Recalls
19
Facilities
Description
The Prolex™ Strep Enzyme Kit provides a rapid platform for the serological identification of beta-haemolytic streptococci belonging to Lancefield groups A, B, C, D, F and G.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-20 | Cypress Medical Products LLC | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices. |
| 2009-04-06 | Binax, Inc. dba IMPD | Potential for false positive Strep A results. |
| 2004-06-11 | Abbott Laboratories HPD/ADD/GPRD | False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control. |
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