Recall Z-1730-2019
Microbiologics Inc · initiated April 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Product with incorrect shelf life.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1730-2019
- Initiated
- April 9, 2019
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Quantity
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1731-2019 Class II | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233…Product with incorrect shelf life. | 04/09/2019Open, Classified |