The Recall Desk
LowFDA (Devices)·Z-2233-2014·Announced 2014-08-20

BD Multi Check CD4 Low Control Recalled for Incorrect Date Labeling

BD Biosciences is recalling 85 units of BD Multi Check CD4 Low Control due to an incorrect distribution date on the outer box label.

What this means for you

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 documentation and labeling error regarding the distribution date, which fits the criteria for a Low severity score.

Plain-English summary

BD Biosciences, Systems & Reagents is recalling 85 units of BD Multi Check CD4 Low Control, Catalog No. 340916, Lot number BM084L. The product is intended as a complete process control for immunophenotyping by flow cytometry.

The recall was initiated because the outer box label contains an incorrect distribution date. The box states the date as 2017-09-02, but it should be 2014-09-02.

The affected units were distributed to locations in Indiana, Massachusetts, Texas, Virginia, California, Kentucky, Maryland, Pennsylvania, Georgia, and BD locations in Singapore and Belgium. Users should stop using the product and contact BD Biosciences for instructions on return or replacement.

The recalled product

Product
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Affected units
85

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 (2)

  • Catalog number 340916
  • Lot number BM084L

Distribution

Distributed in 9 states: