Skip to content
Recall Observatory FDA recall evidence

Device product

PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & 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-0312-2017

June 01, 2016

Class III

Product summary

Firm
Becton Dickinson & Co.
Event
Event 75375
Status
Terminated
Classification
Class III
Quantity
94
Official record key
device-enforcement:Z-0312-2017

Official wording

Reason: BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) 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 Lot / Serial Number. 5327782

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 PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) 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.