—#142202

Product

MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

FDA product code: LTT — Panels, Test, Susceptibility, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 2016-05-06 Part No. B1017-206

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.

Timeline

Recall initiated: 2015-12-01
Terminated: 2016-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.