Device 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.
Z-1272-2013
Product summary
- Event
- Event 64699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,608 boxes = 432,160 panels
- Official record key
device-enforcement:Z-1272-2013
Official wording
Reason: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Code information: All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13.
Distribution pattern: US Nationwide Distribution including Puerto Rico.
Derived failure modes
-
Unknown
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.