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BinaxNOW Streptococcus pneumoniae Antigen Card
Alere Scarborough, Inc. · Model 710-000 · UDI-DI 10811877011061
1
510(k) clearances
39
Adverse events
3
Recalls
19
Facilities
Description
The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis.
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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