Recall Z-1272-2013 ยท LTT Panels, Test, Susceptibility, Antimicrobial
Siemens Healthcare Diagnostics, Inc.
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.
| Date | May 8, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, |
| Quantity | 21,608 boxes = 432,160 panels |
| Distribution | US Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091949 | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 Siemens Healthcare Diagnostics, Jan 26, 2010 |