PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & — Class III medical device recall Z-0312-2017
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 PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782
| Recall number | Z-0312-2017 |
|---|---|
| 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 | 94 |
| Reason classes | labeling |
| Serial numbers | 5327782 |
| Model numbers | 440911 |
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.
Reason for recall
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.
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-0312-2017. 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.