Device recall: Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use…
Class III FDA enforcement event 74452. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Instructions For Use had incorrect lot number and calibrator values
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Tosoh Bioscience, Inc. started this device recall on 7 Jun 2016. The firm address in the FDA record is in South San Francisco, CA. FDA put the recall in Class III. FDA event 74452 has 1 product record. The first FDA enforcement report date is 3 Aug 2016. The record gives the status Terminated, with the termination date 22 Feb 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.
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Recalling firm
Tosoh Bioscience, Inc., South San Francisco, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2282-2016 | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction. | 41 single sets of Progesterone 3 calibrators | Class III | Terminated | 3 Aug 2016 |
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 III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class III
- 5%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 27
Other events of the firm
Official channels
- FDA enforcement report Z-2282-2016The 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 74452. https://recallregister.com/fda/iii/74452/. 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:
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
- What quantity of product is in FDA event 74452?
- The FDA record gives this quantity:
41 single sets of Progesterone 3 calibrators
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 5% of the 1,232 device events that started in 2016 are in Class III.