Z-0312-2017 Class III Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0312-2017 was initiated by Becton Dickinson & Co. on Jun 1, 2016 and is designated Class III. 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 recall status is terminated (terminated Nov 8, 2016). Affected quantity: 94.

Recall Details

Product Type
Devices
Report Date
Nov 2, 2016
Initiation Date
Jun 1, 2016
Termination Date
Nov 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94

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.

Distribution Pattern

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

Code Information

Part/Catalog Number.: 440911 Lot / Serial Number. 5327782

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0312-2017
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

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