BD Max GC RT PCR Assay Recalled for Improperly Sealed Foil Bags
Becton Dickinson is recalling BD Max GC RT PCR Assay kits because foil bags containing extraction tubes may not be sealed properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Becton Dickinson & Co. is recalling 17 units of the BD Max GC RT PCR Assay, Catalog # 443486, Lot # 9092736. The recall is due to a defect where the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly.
The affected products were distributed to 37 U.S. states and territories, as well as 12 international locations including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan. The expiration date for the recalled units is April 25, 2020.
Consumers and healthcare providers should stop using the affected kits and contact Becton Dickinson for further instructions or a replacement.
The recalled product
- Product
- Kit BD Max GC RT PCR Assay; Catalog # 443486
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 17
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 (4)
- Lot # 9092736
- UDI (GTIN
- DI+PI): (01)00382904434861 (17)200425(10)9092736(30)1
- Exp : 4/25/2020
Distribution
Part of a larger recall action
This product is one of 19 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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