Z-0414-2026Class II

Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit...

Name: Z-0414-2026 Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit...
Creator: Cepheid
Published: 2025-08-06
License: https://open.fda.gov/license/

Cepheid / initiated 2025-08-06 / Open, Classified

FDA source

Cepheid began a recall of Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other... on 2025-08-06. FDA classified it as Class II and gives the reason as "As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0414-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-06
Posted: 2025-10-30
Recalling firm: Cepheid
Product: Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for recall: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
FDA root cause: Under Investigation by firm
Action: On 08/21/2025, the firm sent via FedEx an "Urgent Medical Device Recall" to customers to inform customers that Cepheid conducted a routine post-market stability study for GXSACOMP-10 kit batch 1001424179 lot 27815, which failed to meet the half-time stability criteria set for this product. Preliminary investigation indicates that kit batch 1001424181 lot 27816 of the same product may also be impacted. Customers are instructed to: 1. Dispose of GXSACOMP-10 lots 27815 and/or 27816 you have in inventory. Cepheid will provide replacement product. The replacement product should ship within 5 business days following receipt of the completed response form. 2. If you have previously received or receive a negative test result with GXSACOMP-10 lots 27815 or 27816, and the patient shows clinical signs/symptoms of SA or MRSA, re-test with a cartridge from a different lot or use an alternative test/method for SA or MRSA, if available. 3. With all questionable positive or questionable negative results, please continue to report to Cepheid Technical Support for investigation. 4. Cepheid asks that you acknowledge receipt of this Urgent Medical Device Recall by completing the attached Customer Response Form and either emailing the completed form to [email protected] or faxing it to +1 (408) 716-3143. Cepheid will not send a reply or confirmation of received response forms.
Quantity in commerce: 4,132 kits
Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
Product codes and lots: Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0414-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-30

Product code NQX

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)