Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 29, 2014
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 direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time P
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient s…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Co. recalled BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests… - a moderate-severity action.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests… was recalled by Becton Dickinson & Co. in January 29, 2014. Reason: An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved re…. Check the official notice for the remedy. Verify recall #Z-0790-2014 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved re….
- Moderate
- severity level
- Class II
- classification
- January 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0790-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0790-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on October 11, 2013. 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 33 kits.
The documented reason for this recall is: An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples. Distribution data in the federal record shows the product reached: US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.. 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
33 kits
Related Recalls
6
3 from same agency
Product description
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 direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from 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.
Reason for recall
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0790-2014 |
| Date reported | January 29, 2014 |
| Date initiated | October 11, 2013 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 33 kits |
| Distribution | US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA. |
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-0790-2014) 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? ▼
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 direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from 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.. Recalled by Becton Dickinson & Co.. Units affected: 33 kits.
Why was this product recalled? ▼
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0790-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0790-2014) 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 January 29, 2014. 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.