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FDA (Device enforcement)Recalled 2019-07-17closedclass ii

Becton Dickinson & Co.: Kit BD Max GC RT PCR Assay; Catalog # 443486

Is my product affected?

Kit BD Max GC RT PCR Assay; Catalog # 443486

  • UPC 00382904434861

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Co. is recalling the BD Max GC RT PCR Assay (Catalog # 443486) because foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected product is Lot # 9092736 with an expiration date of 4/25/2020, and 17 units were distributed across multiple U.S. states and territories as well as internationally to Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.

The recall notice does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Details from the source

Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan Quantity: 17 units Lot/code info: Lot # 9092736; UDI (GTIN, DI+PI): (01)00382904434861 (17)200425(10)9092736(30)1; Exp : 4/25/2020

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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