BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in partGeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5 BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended

Leakage in Cepheid SmartCycler reaction tubes.

Recall #: Z-2316-2012
Affected scope: 38 kits
Initiated: May 22, 2012

Compiled from official public sources by the publisher. · Updated September 2026

Becton Dickinson & Co. recalled BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Science… - a moderate-severity action.

BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Science… 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-2316-2012 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-2316-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.

Reason for recall

Leakage in Cepheid SmartCycler reaction tubes.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2316-2012
Date reported	September 12, 2012
Date initiated	May 22, 2012
Recalling firm	Becton Dickinson & Co.
Firm location	Sparks, MD
Affected scope	38 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-2316-2012) 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? ▼

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-2316-2012.

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..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Bluestem Brands Recalls Range Rider Ride-… 2012-09-12 Little Remedies For Tummys, Stimulant Lax… 2012-09-12 Bissinger's Campfire S'Mores Salt Caramel… 2012-09-12 Fresh Select Brussels Sprouts, 6x8oz, 9x1… 2012-09-12

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Newport HT70 and HT70 Plus Ventilators, … 2012-09-12 V60 Ventilator, Continuous Ventilator, Mo… 2012-09-12 syngo(R) Lab Data Manager and syngo(R) La… 2012-09-12 Orasure QuickFlu Rapid A+B Test Manufact… 2012-09-12

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported September 12, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026