medical Class II Updated 2020-11-04

Microbiologics Inc recalls Each KWIK-STIK unit contains a lyophilized microorganism pel

Recalled Product

Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.


Hazard / Issue

KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Issued by

FDA

Distribution: Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
Lot/Code Info: Catalog 01145K, Lot 1145-06-5 UDI: 30845357036811
View official government recall

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