FDA Device recall Z-0312-2017
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &
- FDA Device
- Class III
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class III recall of PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & by Becton Dickinson And, citing 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 expiratio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0312-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-01 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA, WI |
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
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.
Identifiers
| code_info | Part/Catalog Number.: 440911 Lot / Serial Number. 5327782 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0312-2017%22
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