Z-0982-2019Class II

Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

Name: Z-0982-2019 Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Creator: Microbiologics Inc
Published: 2019-01-31
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2019-01-31 / Terminated / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use on 2019-01-31. FDA classified it as Class II and gives the reason as "Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0982-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-31
Posted: 2019-03-07
Terminated: 2020-06-09
Recalling firm: Microbiologics, Inc.
Product: Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Product code: PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Reason for recall: Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On about 01/31/2019, Microbiologics notified customers via an "Important Medical Device Correction" letter, sent through email. The letter notified customers of the change in expiration date, instructed customers to update their records with the provided new expiration date, to not use the product after the expiration date, and to complete and return the "MEDICAL DEVICE CORRECTION CUSTOMER RESPONSE FORM." For questions, contact Technical Support at 1-320-229-7064 or [email protected].
Quantity in commerce: 704 units
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, United Kingdom.
Product codes and lots: Catalog Number 8199; Lot Number (original expiration date YYYY/MM/DD, new expiration date YYYY/MM/DD): 8199-02 (2019/02/28, 2018/03/31), 8199-03 (2019/02/28, 2018/03/31), 8199-04 (2019/05/31, 2018/06/30), 8199-05 (2019/05/31, 2018/06/30), 8199-06 (2019/10/31, 2018/11/30), 8199-07 (2019/05/31, 2018/06/30), 8199-08 (2019/12/31, 2019/01/31), 8199-09 (2019/05/31, 2018/06/30), 8199-10 (2020/01/31, 2019/02/28), 8199-11 (2020/01/31, 2019/02/28), 8199-12 (2020/01/31, 2019/02/28), 8199-13 (2020/01/31, 2019/02/28), 8199-17 (2020/04/30, 2019/05/31), 8199-18 (2020/05/31, 2019/06/30), 8199-19 (2020/10/31, 2019/11/30)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0982-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0982-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07

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)