Becton Dickinson Recalls PhoenixSpec AP Calibrator Due to Labeling Error
Becton Dickinson is recalling 94 units of PhoenixSpec AP Calibrator because the expiration date year is incorrectly labeled on the kit.
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 recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling error regarding the expiration date, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Becton Dickinson & Co. is recalling 94 units of the PhoenixSpec AP Calibrator, catalog number 440911, lot number 5327782. The product is used to calibrate PhoenixSpec and Phoenix AP Instruments, which measure the turbidity of microbial suspensions.
The recall was initiated because the calibrator kits are labeled with an incorrect expiration date year. While the expiration dates printed on the individual calibration tubes within the kit are correct, they are difficult to read on a portion of the tubes.
The affected product was distributed to 31 US customers, 22 non-US sites, 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. Non-US distribution included Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand, and Vietnam. Becton Dickinson has contacted all affected customers.
The recalled product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 94
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 (1)
- Part/Catalog Number.: 440911 Lot / Serial Number. 5327782
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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