Recall Z-1522-2015— Beckman Coulter, Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2014-05-14, terminated 2015-04-27. It names one FDA 510(k) clearance: K862140. Product: MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. Reason: Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-14
- Terminated
- 2015-04-27
- Firm location
- West Sacramento, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
Reason for recall
Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
Data sourced from openFDA. This site is unofficial and independent of the FDA.