Microbiologics Inc: KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

Is my product affected?

KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

• UPC 20845357029502

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling KWIK-STIK quality control kits (Catalog #01023P, Lot #1023-05-7) because some units contain an incorrect inner label. The inner label incorrectly identifies the product as Catalog #0919K Haemophilus influenza, when the actual organism contained is Campylobacter coli as intended. The organism itself is correct; only the labeling is wrong. Ten units were affected and distributed worldwide, including across the United States and to Canada, South Africa, France, Netherlands, Mauritius, and China.

The source does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.

Details from the source

Reason for recall: Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China. Quantity: 10 units Lot/code info: Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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