FDA Medical Device Recalls (openFDA)
BioMerieux SA: ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
- Recall number
- Z-2095-2017
- Recalling firm
- BioMerieux SA
- Product
- ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
- Status
- Terminated
- Initiated
- 2017-04-25
- Posted
- 2017-05-03
- Terminated
- 2022-02-24
- Reason
- False susceptible results
- Root cause
- Under Investigation by firm
- Action
- bioMerieux sent an Urgent Product Safety Correction Notice on April 25, 2017 to U. S. consignees. The letter requested that they provide the notice to all appropriate personnel in the laboratory, asking them to identify any possible False Susceptible results. The letter included a Acknowledgment Form to be returned. On this notice the consignee will indicate the number of kits discarded. For customers with questions please contact their local bioMerieux Customer Service representative.
- Quantity
- 3,238 units
- Distribution
- NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY
- Lot, serial or model codes
- REF 531640 Lot Number - 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, 1005442470 --- REF 531600 - was not distributed in the United States
- 510(k) numbers
- ["K020748"]
- PMA numbers
- not on file
- Product code
- JWY
- 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