Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining i
FDA device recall Z-0170-2015 · posted 2014-11-07 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
- Action taken
- Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available. A second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 1381
- Distribution
- Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
- Date initiated
- 2014-10-17
- Date posted
- 2014-11-07
- Date terminated
- 2015-06-29
- Location
- West Sacramento, CA
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