Facility

CEPHEID AB

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009613136
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Rontgenvagen 5 SOLNA Stockholm, SE 17154
Registration status	Active · expires 2026
Parent company	CEPHEID (owner-operator 9062742)
Brand names	Xpert Xpress CoV-2/Flu/RSV plus

Activity by year

Recalls (9)
Inspections (1)

Devices registered here (1)

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Product code QOF (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3981

Recalls & enforcement

Class IIOngoing2025-11-05
Product testing did not meet expected stability criteria.
Class IIOngoing2025-10-30
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class IIOngoing2025-08-06
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class IIOngoing2024-06-20
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.
Class IIOngoing2023-04-24
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Class IITerminated2017-10-09
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of …
Class IITerminated2017-09-15
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Class IITerminated2016-07-18
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Class IIITerminated2015-07-27
Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

FDA inspections (1)

NAI2017-03-15
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CEPHEID AB (FEI 3009613136) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009613136-cepheid-ab/

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