Microbiologics Inc: KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.; 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.; QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Agency Publication Date: October 27, 2020

Affected Products

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.

Catalog 01145P, Lots 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, 1145-07-1 UDI: UDI: 20845357036807

Catalog 01145K, Lot 1145-06-5 UDI: 30845357036811

Lot Numbers:

1145-06-5

Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86576

Status: Resolved

Manufacturer: Microbiologics Inc

Manufactured In: United States

Units Affected: 3 products (30 units; 1 unit; 5 units)

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Sources: FDA iRES · Raw API Response

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