Device recall: Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for…
Class I FDA enforcement event 72755. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Biomerieux started this device recall on 19 Nov 2015. The firm address in the FDA record is in Letoile. FDA put the recall in Class I. FDA event 72755 has 4 product records. The first FDA enforcement report date is 30 Dec 2015. The record gives the status Terminated, with the termination date 19 Jun 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Biomerieux, Letoile, N/A, France.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0439-2016 | Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. | 5458 units | Class I | Terminated | 30 Dec 2015 |
| Z-0440-2016 | Etest PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. | 1216 units | Class I | Terminated | 30 Dec 2015 |
| Z-0441-2016 | Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. | 2495 units | Class I | Terminated | 30 Dec 2015 |
| Z-0442-2016 | 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. | 2422 units | Class I | Terminated | 30 Dec 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class I
- 4%
- Product records in this event
- 4Median of the firm: 5
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Oct 2014 | Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determini | Device | Class III | 5 |
Official channels
- FDA enforcement report Z-0439-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72755. https://recallregister.com/fda/i/72755/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 72755?
- The event has 4 product records. The first record gives this quantity:
5458 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 4% of the 1,153 device events that started in 2015 are in Class I.