Recall Z-0559-2016

Reason for recall

Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.

FDA-determined cause: Device Design

Action taken

The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use and discard any remaining inventory of lots listed; return the attached form for product replacement; retain your inventory of the other lot numbers of the panel types, as they are not impacted by this issue; discuss content of the letter with your laboratory director/staff, retain the notification as part of your laboratory QS documentation; if you have forwarded any of the affected products to another laboratory provide them a copy of the letter, and complete and return the enclosed Response Form within 10 days via mail to: Beckman Coulter, Inc., 1584 Enterprise Blvd., West Sacramento, CA 95691, Attn: Quality Systems & Compliance or Fax: 916-374-2119 or email: MicrobiologyCustomersHCUS@beckman.com. Customers with questions are instructed to contact their Customer Support Representative at http://www.beckmancoulter.com or by phone at (800) 677-7226 in US and Canada.