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Recall Observatory FDA recall evidence

Device product

Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Z-2200-2017

May 05, 2017

Class II

Product summary

Firm
Cell Marque Corporation
Event
Event 77209
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2200-2017

Official wording

Reason: 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.

Code information: 7.0 ml lot 1326605C; expiry 2018-06; 1.0 ml lot 14035068; expiry 2017-01.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.