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EasySep™ Buffer

Stemcell Technologies Canada Inc · Model 100-0780 · UDI-DI 07540207107803

JCC
7
510(k) clearances
164
Adverse events
2
Recalls
47
Facilities

Description

EasySep™ Buffer is a cell separation buffer required for use with EasySep™ IVD Cell Isolation Kit. It contains Dulbecco’s phosphate-buffered saline (PBS) with 2% fetal bovine serum (FBS) and 1 mM EDTA.

Recalls

DateFirmReason
2013-09-13Mesa Laboratories, Inc.Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
2007-04-06Medtronic NeuromodulationMedtronic pH 1.07 buffer solution lot #2610596 was mislableled.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.