H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - An

FDA device recall Z-2202-2017 · posted 2017-06-01 · Terminated

Recall details

Recalling firm

Cell Marque Corporation

Reason for recall

Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.

Action taken

Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.

Root cause

Labeling mix-ups

Status

Terminated

Product code

OWF

Quantity affected

5

Distribution

Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.

Date initiated

2017-05-05

Date posted

2017-06-01

Date terminated

2017-09-07

Location

Rocklin, CA