Z-2095-2017Class II

ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for...

Name: Z-2095-2017 ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for...
Creator: BioMerieux SA
Published: 2017-04-25
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-04-25 / Terminated

FDA source

BioMerieux SA began a recall of ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of... on 2017-04-25. FDA classified it as Class II and gives the reason as "False susceptible results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2095-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2017-05-03
Terminated: 2022-02-24
Recalling firm: bioMerieux, Inc.
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)
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: False susceptible results
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2095-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code JWY

K020748Class IIEtest ErtapenemAb Biodisk / cleared 2002-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)