Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2012
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The t
Leakage in Cepheid SmartCycler reaction tubes.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Co. recalled BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnost… - a moderate-severity action.
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnost… was recalled by Becton Dickinson & Co. in September 12, 2012. Reason: Leakage in Cepheid SmartCycler reaction tubes.. Check the official notice for the remedy. Verify recall #Z-2318-2012 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-Leakage in Cepheid SmartCycler reaction tubes..
- Moderate
- severity level
- Class II
- classification
- September 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2318-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2318-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on May 22, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 57 kits.
The documented reason for this recall is: Leakage in Cepheid SmartCycler reaction tubes. Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.. 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
57 kits
Related Recalls
6
3 from same agency
Product description
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
Reason for recall
Leakage in Cepheid SmartCycler reaction tubes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2318-2012 |
| Date reported | September 12, 2012 |
| Date initiated | May 22, 2012 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 57 kits |
| Distribution | Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV. |
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-2318-2012) 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? ▼
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.. Recalled by Becton Dickinson & Co.. Units affected: 57 kits.
Why was this product recalled? ▼
Leakage in Cepheid SmartCycler reaction tubes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Moderate. Recall number: Z-2318-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2318-2012) 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 September 12, 2012. 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.