Reported Jun 7, 2017 · Terminated

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In…

Cell Marque Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cell Marque Corporation · 6600 Sierra College Blvd · Rocklin, CA · 95677-4306

Is this the product you have?

  • CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Lot codes and dates
    • 1.0 ml lot 16175038
    • expiry 2019-05
    • 7.0 mL lot 1617502A
    • expiry 2019-05
    • lot 16175020
    • expiry 2019-05 and lot 1511403J
    • expiry 2018-03
Amount recalled
12

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Cell Marque Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 7, 2017 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.