Microbiologics Inc: Medical Device Recall in 2019 - (Recall #: Z-1730-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Product Classification:

Class II

Date Initiated: April 9, 2019

Date Posted: June 12, 2019

Recall Number: Z-1730-2019

Event ID: 82783

Reason for Recall:

Product with incorrect shelf life.

Status: Ongoing

Product Quantity: 249

Code Information:

Cepheid Xpert MRSA/MRSA NxG Control Panel Catalog Number 8195 Lot Numbers: 8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, and 8195-10. Cepheid Xpert¿ SA Nasal Complete Control Panel Catalog Number 8196 Lot Numbers: 8196-04, 8196-05, 8196-06, 8196-07, 8196-08 8196-09, 8196-10, and 8196-14.

Distribution Pattern:

Worldwide Distribution - US Nationwide AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MI, MO,MS, MT, NC, ND, NJ, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, and WY. Australia, Chile, Germany, New Zealand, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated