Recall Z-1730-2019— Microbiologics Inc
Class II · Ongoing
Class II FDA medical device recall by Microbiologics Inc, initiated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Product with incorrect shelf life..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-04-09
- Firm location
- Saint Cloud, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.