—#135379

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

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K862140
Affected lot / code info: Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

Distribution pattern: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.

Timeline

Recall initiated: 2014-05-14
Posted by FDA: 2015-04-26
Terminated: 2015-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.