Recall Z-1532-2015— Beckman Coulter, Inc.

Name: FDA recall Z-1532-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-08

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2014-08-08, terminated 2015-04-27. It names one FDA 510(k) clearance: K870074. Product: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.. Reason: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Terminated: 2015-04-27
Firm location: West Sacramento, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K870074 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELSMicroscan Div. Baxter Healthcare Corp.·cleared 1987-04-14

K-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 Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Reason for recall

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Data sourced from openFDA. This site is unofficial and independent of the FDA.