Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.

FDA device recall Z-0252-2016 · posted 2015-11-09 · Terminated

Recall details

Recalling firm

Biocare Medical, LLC

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

NJT

Quantity affected

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,

Date initiated

2015-09-08

Date posted

2015-11-09

Date terminated

2016-01-11

Location

Concord, CA