Becton Dickinson Recalls PhoenixSpec Calibrator Kits Due to Labeling Error
Becton Dickinson is recalling specific lots of BBL PhoenixSpec Calibrator kits because the kits are labeled with an incorrect expiration year, although the individual tubes have correct dates.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration year on the outer kit packaging.
Plain-English summary
Becton Dickinson & Co. is recalling 20 units of BBL PhoenixSpec Calibrator kits, catalog numbers 440911 and 441951, from lots 5364776 and 5345796. The recall is due to a labeling error where the kits are marked with an incorrect expiration year. The expiration dates printed on the individual calibration tubes within the kits are correct, but they are difficult to read on a portion of the tubes.
The affected products were distributed to 31 US customers, 22 sites outside the US, and 4 US government sites. US distribution included shipments to Alabama, California, Colorado, Kentucky, Maryland, Michigan, Mississippi, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington, and Wisconsin. International distribution included Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand, and Vietnam.
Becton Dickinson has contacted all affected customers. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences. Users should check the expiration dates on the individual tubes and contact Becton Dickinson for further instructions.
The recalled product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part/Catalog Number.: 440911
- 441951 Lot / Serial Number. :5364776
- 5345796
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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