Recall Z-0312-2017— Becton Dickinson & Co.

Name: FDA recall Z-0312-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-01

Class III · Terminated

Class III FDA medical device recall by Becton Dickinson & Co., initiated 2016-06-01, terminated 2016-11-08. It names one FDA 510(k) clearance: K023301. 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class III
Status: Terminated
Initiated: 2016-06-01
Terminated: 2016-11-08
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K023301 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEMBecton, Dickinson & CO·cleared 2002-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.