BD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing
Becton Dickinson is recalling 33 kits of the BD GeneOhm Cdiff Assay because an incorrect reagent was packed, which may cause false negative results for C. difficile.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic test where an error may lead to false negative results for a serious pathogen (C. difficile), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Becton Dickinson & Co. is recalling 33 kits of the BD GeneOhm Cdiff Assay, Part #441401. The recall involves kits containing Lysis Kit sample buffer tubes, with 200 tests per kit. The specific lot number is 08T13108, with an expiration date of December 24, 2013.
The recall was initiated because an incorrect reagent was packed with the in vitro diagnostic kit. This error may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples. The BD GeneOhm Cdiff Assay is a rapid in vitro diagnostic test intended for the direct, qualitative detection of the C. difficile toxin B gene in human stool specimens from patients suspected of having Clostridium difficile-associated disease.
The affected products were distributed in the United States, including the states of New York, Indiana, Utah, Minnesota, Ohio, Massachusetts, South Dakota, California, New Jersey, and Pennsylvania. Healthcare facilities and laboratories that have received this product should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 33
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)
- Lot 08T13108 Exp Dec 24 2013
Distribution
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