Siemens MicroScan MICroSTREP panels recalled for false susceptibility results
Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect antimicrobial susceptibility results) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 21,608 boxes (432,160 panels) of MicroScan MICroSTREP plus Type 1 B1027-201 panels. These panels are designed to determine antimicrobial agent susceptibility for aerobic nonenterococcal streptococci and Haemophilus species.
The recall was initiated after a customer complaint investigation confirmed that the panels may produce false skipped wells and false susceptible misreads when testing Streptococcus agalactiae (Group B Streptococcus) against multiple antimicrobial agents. This defect could lead to incorrect clinical decisions regarding antibiotic treatment.
The affected units were distributed nationwide in the United States, including Puerto Rico. The recall includes all lots with expiration dates ranging from February 24, 2013, to February 13, 2014. Healthcare facilities and laboratories should stop using these panels and contact Siemens for instructions on returning or disposing of the product.
The recalled product
- Product
- Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
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