FDAFDA · Food and drugs·Recall number Z-0561-2016
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 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.
Published January 6, 2016 · Recall initiated: December 1, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- 2016-04-30 Part No. B1017-202
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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