Z-0442-2016Class I

Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the...

Name: Z-0442-2016 Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the...
Creator: Biomerieux
Published: 2015-11-19
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-11-19 / Terminated

FDA source

Biomerieux began a recall of Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and... on 2015-11-19. FDA classified it as Class I and gives the reason as "Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0442-2016
Classification: Class I
Status: Terminated
Initiated: 2015-11-19
Posted: 2015-12-23
Terminated: 2017-06-19
Recalling firm: bioMerieux, Inc.
Product: Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
FDA root cause: Process change control
Action: Consignees (Subsidiaries and Distributors) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioMrieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015.
Quantity in commerce: 2422 units
Distribution: Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
Product codes and lots: Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0442-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0439-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0440-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0441-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0442-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code JWY

K953223Class IIPiperacilin Tazobactam 4 UgAb Biodisk / cleared 1995-08-15

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)