Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk
Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for biohazard exposure and false positive test results. No illnesses or injuries reported in the source; the hazard is theoretical, so the score is limited to High (3) per the severity rubric.
Plain-English summary
Cepheid is recalling 651,150 specimen collection devices (Part 900-0370) used in medical testing facilities. These devices are distributed worldwide, including across all US states and more than 25 countries.
The recalled devices may leak after patient sample swabs are inserted into test tubes. This leakage creates risk of biohazard exposure, cross-contamination that can produce false positive test results for other specimens, and delays in reporting results.
Affected lots include 230397900, 230535300, 230627500, and 231877400, with various expiration dates between July 2024 and April 2025. Healthcare facilities and testing laboratories using these devices should stop use of affected lots immediately and contact Cepheid for guidance on replacement or return procedures.
The recalled product
- Product
- Cepheid, Sample Collection Device, Part: 900-0370
- Manufacturer
- Cepheid
- Affected units
- 651,150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3
- 2024
- 230535300/ July 14
- 230627500/ August 4
- 231877400/ April 10
- 2025
Distribution
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