Becton Dickinson PrepStain Tecan US-I Recall for Incorrect Rack Settings
Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.
What this means for you
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 describes a configuration error during maintenance without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Becton Dickinson & Co. is recalling 890 PrepStain Tecan US-I instruments. These devices are used for the screening and detection of cervical cancer. The recall involves catalog numbers 799-13000-00 and 799-13000-00R.
The recall was initiated because a rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. The agency classifies this as a Class II recall.
The affected units were distributed nationwide in the United States, in Puerto Rico, and in Canada. Users of these devices should contact Becton Dickinson & Co. for further instructions on how to proceed.
The recalled product
- Product
- PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 890
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 (1)
- Catalog Numbers - 799-13000-00 and 799-13000-00R
Distribution
Part of a larger recall action
This product is one of 3 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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