CLASS III Device recall · Reported 2 Nov 2016 · FDA Enforcement Report
PhoenixSpec Calibrator & Kit is used to calibrate recalled
Becton Dickinson & is recalling PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP, distributed in 17 states. The recall was initiated on 1 Jun 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0311-2017
- FDA event ID
- 75375
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Jun 2016
- FDA classified
- 25 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2016 | Recall initiated by company | |
| 25 Oct 2016 | Classified by FDA | +146 days |
| 2 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
PhoenixSpec Calibrator & Kit 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.
Where it was distributed
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
AlabamaCaliforniaColoradoKentuckyMarylandMichiganMississippiNebraskaNew JerseyOhioPennsylvaniaSouth CarolinaSouth DakotaTexasVirginiaWashingtonWisconsin
Questions about this recall
Is PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP recalled?
Yes. Becton Dickinson & recalled PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP on 1 Jun 2016. The recall is Class III and its status is Terminated. Recall number Z-0311-2017.
Why was it recalled?
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.
Which lots are affected?
Part/Catalog Number.: 440911, 441951 Lot / Serial Number. :5364776, 5345796
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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