Home › PRO-LAB, INCORPORATED › Prolex Streptococcal Grouping Reagent Latex Suspension Group F
Prolex Streptococcal Grouping Reagent Latex Suspension Group F
PRO-LAB, INCORPORATED · Model PL.035 · UDI-DI 10628429000196
10
510(k) clearances
39
Adverse events
3
Recalls
19
Facilities
Description
Grouping Reagent F, for the rapid latex agglutination test, 60 tests Grouping reagent for the rapid latex agglutination test for the identification of streptoccoccal groups.
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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