Loading...
Loading...
All product recalls associated with Biosite Inc.
Total Recalls
7
Past Year
0
Class I (Serious)
0
Most Recent
Apr 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result
False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.