Reported Oct 23, 2013 · Terminated
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The…
Sekisui Diagnostics LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sekisui Diagnostics LLC · 6659 Top Gun St · San Diego, CA · 92121-4113
Is this the product you have?
- Product NameOSOM C. Difficile
- Toxin A/B Test Catalog Numbers173 (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 blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD
- Lot codes and dates
- The following are part numbers and lot number combinations
- PN173E
- LN121272
- PN173
- LN121273
- PN173
- LN121273A
- PN173E
- LN131155
- PN173
- LN131156
- Amount recalled
- 391 kits
Where it was sold
- Nationwide
Why it was recalled
Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
This product could cause temporary or reversible health problems — stop using it.
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