FDA recall Z-2335-2019

Product

Kit BD Max GC RT PCR Assay; Catalog # 443486

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Distribution

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

Key facts

Status

Terminated

Initiation date

2019-07-17

Report date

2019-08-28

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2019