Becton Dickinson & Co. recalls PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then…

Recall date

June 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0311-2017

FDA classification

Class III

Brand / firm

Becton Dickinson & Co.

Sold / distributed

BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and V…

Why it was recalled

BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.