BD" Mouse IgG2a Isotype Control APC X39 ASR
Check against the official notice below — it lists the full affected range.
Becton, Dickinson and Company is recalling BD Mouse IgG2a Isotype Control APC X39 ASR (Catalog Number 340757, Lot Number 0253432) due to a manufacturing process error that caused contamination with another antibody. This contamination can result in high background staining and false positive results during testing. The affected product was distributed worldwide, including in the U.S. states of Connecticut, Florida, Kentucky, New York, and Pennsylvania, as well as Taiwan, with 23 reagents involved in the recall.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
Reason for recall: Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan. Quantity: 23 reagents Lot/code info: Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.