Z-0252-2016Class II

Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml...

Name: Z-0252-2016 Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml...
Creator: Biocare Medical, LLC
Published: 2015-09-08
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2015-09-08 / Terminated / root cause: design

FDA source

Biocare Medical, LLC began a recall of 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... on 2015-09-08. FDA classified it as Class II and gives the reason as "Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0252-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Posted: 2015-11-09
Terminated: 2016-01-11
Recalling firm: Biocare Medical LLC
Product: 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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: design
FDA root cause: Device Design
Action: Biocare sent a Medical Device Recall Notification letter dated September 8, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue and dispose of all affected product. Customers were asked to complete an return the enclosed Return Response Form. Customer's accounts would be credited for all affected product. For questions regarding this recall call 925-603-8033.
Quantity in commerce: 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, Bolivia, Mexico, Indonesia and Australia.
Product codes and lots: Catalog numbers: CME305A & CME305B: lots 110112, Expiry 11/2015;0 42213, expiry 4/2016; 101013, expiry 10/2016; 121813, expiry 12/2016; 070214, expiry 7/2017; 020215, expiry 2/2018. Catalog number: PME305AA, lots 070513, expiry 07/2016; 032114, expiry 3/2017, 030315, expiry 3/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0252-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0252-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)