FDA Device recall Z-1731-2019
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTI…
- FDA Device
- Class II
- ongoing
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTI… by Microbiologics, citing product with incorrect shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1731-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-04-09 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1731-2019%22
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