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Recall Observatory FDA recall evidence

Device product

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.

Z-0311-2017

June 01, 2016

Class III

Product summary

Firm
Becton Dickinson & Co.
Event
Event 75375
Status
Terminated
Classification
Class III
Quantity
20
Official record key
device-enforcement:Z-0311-2017

Official wording

Reason: 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.

Code information: Part/Catalog Number.: 440911, 441951 Lot / Serial Number. :5364776, 5345796

Distribution pattern: 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 Vietnam 4 US government sites were contacted

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.