Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 23, 2013
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 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
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 fo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sekisui Diagnostics LLC recalled Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) … - a moderate-severity action.
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) … was recalled by Sekisui Diagnostics LLC in October 23, 2013. Reason: Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A…. Check the official notice for the remedy. Verify recall #Z-0015-2014 with the FDA Devices before acting.
The recall
Sekisui Diagnostics LLC issued this moderate-severity FDA Devices recall-Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A….
- Moderate
- severity level
- Class II
- classification
- October 23, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0015-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0015-2014) was formally reported on October 23, 2013, with the manufacturer initiating the action on September 16, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Sekisui Diagnostics LLC is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 391 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
391 kits
Related Recalls
6
3 from same agency
Product description
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 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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0015-2014 |
| Date reported | October 23, 2013 |
| Date initiated | September 16, 2013 |
| Recalling firm | Sekisui Diagnostics LLC |
| Firm location | San Diego, CA |
| Affected scope | 391 kits |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0015-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 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.. Recalled by Sekisui Diagnostics LLC. Units affected: 391 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2013. Severity: Moderate. Recall number: Z-0015-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0015-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 23, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.