Z-1731-2019Class II

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233

Name: Z-1731-2019 Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233
Creator: Microbiologics Inc
Published: 2019-04-09
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2019-04-09 / Open, Classified

FDA source

Microbiologics Inc began a recall of Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL... on 2019-04-09. FDA classified it as Class II and gives the reason as "Product with incorrect shelf life". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1731-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-04-09
Posted: 2019-06-04
Recalling firm: Microbiologics, Inc.
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.
Product code: PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Reason for recall: Product with incorrect shelf life.
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 235
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1731-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1730-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1731-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code PMN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)