BD CD3 FITC Recalled for Spanish Labeling Error
Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.
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 by definition is unlikely to cause adverse health consequences. The hazard is limited to a minor labeling error in the Spanish text.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic (IVD) reagents. The product is used in hematology to react with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. The recall involves Catalog # 349201 (Lot 5148598, expires 10-31-2016) and Catalog # 340542 (Lot 5113983, expires 02-28-2017).
The reason for the recall is an error in the Spanish small text on the product label. This is a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected units were distributed nationwide in the United States to the states of TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC, OK, NC, and LA, as well as internationally to Mexico. Users should check their inventory for the specific catalog and lot numbers listed above and contact the manufacturer for further instructions.
The recalled product
- Product
- BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- Affected units
- 120
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)
- Catalog Number: 349201
- Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542
- Lot Number 5113983 (expires 02-28-2017)
Distribution
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