Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 18, 2015
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biocare Medical, LLC recalled Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml;… - a moderate-severity action.
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml;… was recalled by Biocare Medical, LLC in November 18, 2015. Reason: Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected…. Check the official notice for the remedy. Verify recall #Z-0252-2016 with the FDA Devices before acting.
The recall
Biocare Medical, LLC issued this moderate-severity FDA Devices recall-Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected….
- Moderate
- severity level
- 151 units
- affected scope
- Class II
- classification
- November 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0252-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0252-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on September 8, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Biocare Medical, LLC is listed as the recalling firm, operating out of Concord, CA. Federal records list the affected scope as 151 units.
The documented reason for this recall is: Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA, KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, C…. 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
151 units
Related Recalls
6
3 from same agency
Product description
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
Reason for recall
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0252-2016 |
| Date reported | November 18, 2015 |
| Date initiated | September 8, 2015 |
| Recalling firm | Biocare Medical, LLC |
| Firm location | Concord, CA |
| Affected scope | 151 units |
| Distribution | Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA, KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivi… |
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-0252-2016) 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? ▼
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.. Recalled by Biocare Medical, LLC. Units affected: 151 units.
Why was this product recalled? ▼
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0252-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA, KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia and Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0252-2016) 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 November 18, 2015. 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.