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Z-0311-2017 Class III Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0311-2017 was initiated by Becton Dickinson & Co. on Jun 1, 2016 and is designated Class III. 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… The recall status is terminated (terminated Nov 8, 2016). Affected quantity: 20.

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: 20

Product Description

PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 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 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.

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, 441951 Lot / Serial Number. :5364776, 5345796

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0311-2017
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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