Xpert SA Nasal Complete recallZ-0414-2026 · Cepheid · initiated Aug 6, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Cepheid or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-0414-2026
Status: Open, Classified
Initiated by the company: Aug 6, 2025
Posted by the FDA: Oct 30, 2025
Recalling firm: Cepheid
Quantity: 4,132 kits
Product code: NQX
FDA submissions: K100822, K243070
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 description

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

Code information (models, lots, serial numbers)

Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Xpert SA Nasal Complete GXSACOMP-10
Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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