FDA Medical Device Recalls (openFDA)
BioMerieux SA: NucliSENS Lysis Buffer Extended lot for RES 76675
- Recall number
- Z-0086-2018
- Recalling firm
- BioMerieux SA
- Product
- NucliSENS Lysis Buffer Extended lot for RES 76675
- Status
- Terminated
- Initiated
- 2017-10-18
- Posted
- not on file
- Terminated
- 2021-08-24
- Reason
- Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
- Root cause
- Nonconforming Material/Component
- Action
- US customers were notified on 10/18/2017 via letter using 2-day Fed Ex shipment. Instructions included notifying all appropriate personnel in the laboratory or to customers if product was further distributed, refrain from using the affected product, and arrange for replacement of affected product by completing and returning the response form. It also instructed customers to contact and discuss any concerns regarding previously reported results with the appropriate Laboratory Medical Director to determine an appropriate course of action.
- Quantity
- 911 units
- Distribution
- Distributed domestically to MD, CO, and OH.
- Lot, serial or model codes
- REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
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