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.
Reported: June 12, 2019 Initiated: April 9, 2019 #Z-1730-2019
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.
Reason for Recall
Product with incorrect shelf life.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 249
- Distribution
- 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.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microbiologics Inc. Units affected: 249.
Why was this product recalled? ▼
Product with incorrect shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1730-2019.
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