ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister… recallZ-2095-2017 · BioMerieux SA · initiated Apr 25, 2017

Class II Terminated All recalls posted in May 2017

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from BioMerieux SA or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

False susceptible results

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-2095-2017
Recall class: Class II
Status: Terminated
Initiated by the company: Apr 25, 2017
Posted by the FDA: May 3, 2017
Recalling firm: BioMerieux SA
Quantity: 3,238 units
Product code: JWY
FDA submissions: K020748
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

Product description

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)

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K020748 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

ETEST® Ertapenem (ETP)
Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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