Class 2 Device Recall Xpert SA Nasal Complete

• Date Initiated by Firm: August 06, 2025
• Date Posted: October 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0414-2026
• Recall Event ID: 97497
• 510(K)Number: K100822 K243070
• Product Classification: System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen - Product Code NQX
• 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
• Code Information: Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181
• FEI Number: 3004530258
• Recalling Firm/ Manufacturer: Cepheid; 904 E Caribbean Dr; Sunnyvale CA 94089-1189
• For Additional Information Contact: Darwa Peterson; 408-242-7380
• Manufacturer 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 Determined 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 CFQ@cepheid.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NQX; 510(K)s with Product Code = NQX