OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk
Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.
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 3/5 (High).
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 medical diagnostic device with a potential for false negative results, which poses a risk of harm by potentially delaying correct diagnosis and treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Sekisui Diagnostics LLC has issued a Product Correction for certain lot numbers of the OSOM C. Difficile Toxin A/B Test Kit. The recall involves 391 kits distributed worldwide, including the United States, UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India, and Romania. The affected product is a qualitative in vitro diagnostic assay used to detect Clostridium difficile toxins A and/or B in human stool samples to aid in the diagnosis of C. difficile associated disease.
The recall was initiated because it has been determined that there is a potential for false negative results. The specific part number and lot number combinations affected are: PN:173E, LN:121272; PN:173, LN:121273; PN:173, LN:121273A; PN:173E, LN:131155; and PN:173, LN:131156.
Healthcare facilities and distributors should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or authorized distributor in accordance with the recall instructions.
The recalled product
- Product
- Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a…
- Manufacturer
- Sekisui Diagnostics LLC
- Affected units
- 391
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 (6)
- The following are part numbers and lot number combinations. PN:173E
- LN:121272. PN:173
- LN:121273. PN:173
- LN:121273A. PN:173E
- LN:131155. PN:173
- LN:131156.
Distribution
Distributed nationwide across the United States.
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