Z-0311-2017Class III

PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments...

Name: Z-0311-2017 PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments...
Creator: Becton Dickinson & Co.
Published: 2016-06-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-06-01 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial... on 2016-06-01. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0311-2017
Classification: Class III
Status: Terminated
Initiated: 2016-06-01
Posted: 2016-10-25
Terminated: 2016-11-08
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement
Quantity in commerce: 20
Distribution: 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
Product codes and lots: Part/Catalog Number.: 440911, 441951 Lot / Serial Number. :5364776, 5345796

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0311-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0312-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25

Product code LON

K023301Class IIBd Phoenix Automated Microbiology SystemBecton, Dickinson & CO / cleared 2002-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)