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.
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 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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