PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec… — Class III medical device recall Z-0311-2017

Terminated recall by Becton Dickinson & Co., reported 2016-11-02, distributed in AL, CA, CO, KY, MD, MI, MS, NE…. BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (

Recall number	`Z-0311-2017`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Becton Dickinson & Co., Sparks, MD, United States
Recall initiated	2016-06-01
Classified	2016-10-25
Reported by FDA	2016-11-02
Terminated	2016-11-08
Distributed	AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA, WI
Countries outside the US	AR, CA, CN, EC, IN, JP, NZ, PE, SG, TH, VN
Quantity	20
Reason classes	labeling
Serial numbers	`5345796`, `5364776`
Model numbers	`440911`, `441951`

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0311-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.