FDA Medical Device Recalls (openFDA)
Accelerate Diagnostics Inc: Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
- Recall number
- Z-1529-2018
- Recalling firm
- Accelerate Diagnostics Inc
- Product
- Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
- Status
- Terminated
- Initiated
- 2018-03-14
- Posted
- not on file
- Terminated
- 2023-01-17
- Reason
- The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
- Root cause
- Under Investigation by firm
- Action
- The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.
- Quantity
- 95 kits
- Distribution
- Distributed to IL, TX, CA, SC, and DE.
- Lot, serial or model codes
- Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PRH
- Firm FEI
- 3010671651
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28