FDA-Device2023-07-05Class II
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Hazard
Reagent lot numbers include an insufficient concentration of blocking reagent.
Sold states
Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.
Affected count
987 kits
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2043-2023More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- FDA-Device2026-04-15MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- 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.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
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