StrepPRO™
HARDY DIAGNOSTICS · Model PL030HD · UDI-DI 00819398027984
Description
StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefield grouping, 60 tests A unique streptococcal grouping latex agglutination kit for the rapid identification of group A, B, C, D, F, and G Streptococcus from culture. Each kit contains: * PL031HD Blue Latex Suspension Group A, 3ml 1 vial/kit (00819398027854) * PL032HD Blue Latex Suspension Group B, 3ml 1 vial/kit (00819398027861) * PL033HD Blue Latex Suspension Group C, 3ml 1 vial/kit (00819398027878) * PL034HD Blue Latex Suspension Group D, 3ml 1 vial/kit (00819398027885) * PL035HD Blue Latex Suspension Group F, 3ml 1 vial/kit (00819398027892) * PL036HD Blue Latex Suspension Group G, 3ml 1 vial/kit (00819398027908) * PL037HD Extraction Reagent 1, 3.5ml 1 vial/kit (00819398027915) * PL038HD Extraction Reagent 2, 3.5ml 1 vial/kit (00819398027922) * PL039HD Extraction Reagent 3, 8.5ml 2 vials/kit (00819398027939) * PL040HD Polyvalent Positive Control, 3.5ml 1 vial/kit (00819398027946) * PL092HD Latex Test Cards 48 cards/kit (00819398027977) * Mixing Sticks 300 sticks/kit (00819398027960)
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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