FDA Medical Device Recalls (openFDA)
Epigenomics Ag: Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
- Recall number
- Z-1077-2018
- Recalling firm
- Epigenomics Ag
- Product
- Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
- Status
- Terminated
- Initiated
- 2017-11-02
- Posted
- not on file
- Terminated
- 2018-06-19
- Reason
- The diagnostic test kit may produce invalid test runs which may delay test results.
- Root cause
- Unknown/Undetermined by firm
- Action
- Users were instructed to discontinue use of the kits, complete the acknowledgement form, and distribute the notification to relevant persons within organization. If kits were further distributed the consignee was asked to forward the safety notice to these entities.
- Quantity
- 200
- Distribution
- Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
- Lot, serial or model codes
- Lot Number: 16903908; Expiration Date: 28 Feb 2018
- 510(k) numbers
- not on file
- PMA numbers
- ["P130001"]
- Product code
- PHP
- Firm FEI
- 3005968611
- Firm city
- Berlin
- Firm state
- not on file
- Firm country
- Germany
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