CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Ctstm Essential 8 Medium recalled by Life Technologies

Life Technologies is recalling Ctstm Essential 8 Medium, distributed in 26 states. The recall was initiated on 11 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSKU: A2656001 Lot: 1955886 (Exp1/30/2019), 1960951 (Exp1/30/2019), 2039735 (Exp1/30/2020)

Quantity recalled3693 Kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0275-2020
FDA event ID: 83301
Recalling firm: Life Technologies, Grand Island, NY
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2019
FDA classified: 6 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Jun 2019	Recall initiated by company
6 Nov 2019	Classified by FDA	+148 days
13 Nov 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Component was not tested by the supplier for adventitious agents

Product as listed by the FDA

CTSTM Essential 8 Medium

Where it was distributed

StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI. StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Malaysia, Netherlands, Pakistan, Poland, Republic of Korea, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam. CTSTM Essential 8 Medium distributed to the following states in the USA: CA, DC, FL, IA, IL, MA, MD, MN, NC, NY, WA, WI. CTSTM Essential 8 Medium distributed Internationally to the following countries: Australia, Canada, China, France, Germany, India, Japan, Netherlands, Portugal, Republic of Korea, Saudi Arabia, Singapore, Sweden, Switzerland, Taiwan, United Kingdom.

Alabama California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Massachusetts Maryland Minnesota North Carolina Nebraska New Jersey New York Ohio Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Component was not tested by the supplier for adventitious agents

Which lots are affected?

SKU: A2656001 Lot: 1955886 (Exp1/30/2019), 1960951 (Exp1/30/2019), 2039735 (Exp1/30/2020)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 83301

This product is part of a recall event; the main page for the event is StemPro¿ MSC SFM CTS" recalled by Life Technologies.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS II	StemPro¿ MSC SFM CTS" recalled by Life Technologies	Life Technologies	Other	26 states

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